Guidance for Industry and FDA Staff 
 
Hemodialysis Blood Tubing Sets - 
Premarket Notification [510(k)] 
Submissions 
 
 
Document issued on: April 23, 2008  
 
This document supersedes Hemodialysis Blood Tubing Sets - Premarket 
Notification [510(k)] Submissions dated April 14, 2008. 
 
 
For questions regarding this document, contact Mr. Joshua Nipper at 240-276-4151 or via email at 
joshua.nipper@fda.hhs.gov. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Gastroenterology and Renal Devices Branch 
Reproductive, Abdominal, and Radiological Devices Division 
Office of Device Evaluation 
 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration to the  
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to the exact title of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated. 
 
Additional Copies 
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/[specific address].  
You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the 
guidance or send a fax request to 240-276-3151 to receive a hard copy.  Please use the document 
number (1649) to identify the guidance you are requesting. 
 
 
  Contains Nonbinding Recommendations 
 
Table of Contents 
1.  INTRODUCTION...................................................................................................................1 
2.  BACKGROUND.....................................................................................................................2 
3.  THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION......2 
4.  SCOPE.....................................................................................................................................5 
5.  DEVICE DESCRIPTION......................................................................................................5 
6.  RISKS TO HEALTH..............................................................................................................6 
7.  PERFORMANCE TESTING................................................................................................7 
8.  DEVICE MATERIALS AND BIOCOMPATIBILITY......................................................8 
9.  STERILITY.............................................................................................................................8 
10.   EXPIRATION DATE TESTING..........................................................................................9 
11.   LABELING.............................................................................................................................9 
APPENDIX I.  GLOSSARY OF TERMS.................................................................................12 
 
 
  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Hemodialysis Blood Tubing Sets - Premarket 
Notification [510(k)] Submissions 
 
This guidance represents the Food and Drug Administrations (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
 
1.  Introduction 
This guidance document is intended to assist industry in preparing an Abbreviated premarket 
notification submission (510(k)) to establish that the device is substantially equivalent to a 
predicate hemodialysis blood tubing set for use as the extracorporeal blood circuit during 
hemodialysis treatment.  This guidance document identifies specific recommendations for the 
content and format of an Abbreviated 510(k) submission for hemodialysis blood tubing sets.  This 
version of the guidance is intended to clarify the April 14, 2008, guidance of the same title and is 
consistent with FDAs original approach to premarket notification (510(k)) submissions. 
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe need to be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered the 
burden that may be incurred in your attempt to follow the guidance and address the issues we 
have identified.  We believe that we have considered the least burdensome approach to 
resolving the issues presented in the guidance document.  If, however, you believe that there 
is a less burdensome way to address the issues, you should follow the procedures outlined in 
the "A Suggested Approach to Resolving Least Burdensome Issues" document.  It is available 
on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
1  Contains Nonbinding Recommendations 
 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
2.  Background 
A manufacturer who intends to market a device of this generic type must conform to the general 
controls of the Federal Food, Drug, and Cosmetic Act (the act), including the premarket 
notification requirements described in 21 CFR 807 Subpart E, and obtain a substantial 
equivalence determination from FDA prior to marketing the device. (See also 21 CFR 807.81 and 
807.87.)  
 
This guidance document identifies the classification regulation and product codes for 
hemodialysis blood tubing sets (refer to Section 4. Scope).  Other sections of this guidance 
document provide additional information to manufacturers on addressing risks related to these 
devices in premarket notifications (510(k)s).  
 
This document supplements other FDA documents regarding the specific content requirements of 
a premarket notification submission.  You should also refer to 21 CFR 807.87, the guidance, 
Format for Traditional and Abbreviated 510(k)s,1 and Premarket Notification 510(k) on 
CDRH Device Advice.2
 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications,3 a manufacturer may submit a Traditional 510(k) or 
has the option of submitting either an Abbreviated 510(k) or a Special 510(k). FDA believes an 
Abbreviated 510(k) provides the least burdensome means of demonstrating substantial 
equivalence for a new device, particularly once FDA has issued a guidance document addressing 
that device. Manufacturers considering certain modifications to their own cleared devices may 
lessen the regulatory burden by submitting a Special 510(k). 
 
3.  The Content and Format of an Abbreviated 510(k) 
Submission  
An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 
807.87, including the proposed labeling for the device sufficient to describe the device, its 
intended use, and the directions for its use.  In an Abbreviated 510(k), we recommend that you 
include an abbreviated 510(k) summary report of appropriate supporting data within the meaning 
of 21 CFR 807.87(f) or (g).  The abbreviated 510(k) summary report should explain how this 
guidance document was used during the device development and testing, briefly describe the 
methods or tests used, and include a summary of the test data or description of the acceptance 
criteria applied to address the risks identified in this document and any other additional risks 
                                                 
1 http://www.fda.gov/cdrh/ode/guidance/1567.html
2 http://www.fda.gov/cdrh/devadvice/314.html  
3 http://www.fda.gov/cdrh/ode/parad510.html  
2  Contains Nonbinding Recommendations 
 
specific to your device.  This section suggests information to fulfill some of the requirements of 
section 21 CFR 807.87 and identifies other items that we recommend you include in an 
Abbreviated 510(k).  
 
Coversheet 
The coversheet should prominently identify the submission as an Abbreviated 510(k) and cite 
the title of this guidance document. 
 
Proposed Labeling 
Proposed labeling must be sufficient to describe the device, its intended use, and the 
directions for its use.  (21 CFR 807.87(e).)  (Please refer to Section 11.  Labeling for specific 
information that should be included in the labeling for devices of the type covered by this 
guidance document.) 
 
4
Abbreviated 510(k) Summary Report
In accordance with 21 CFR 807.87, your abbreviated 510(k) summary report should contain 
the following:  
 
Description of the device and its intended use   
We recommend that you describe the device and include an explanation of how the device 
functions and the specific physical and performance characteristics of the device.  (Please 
refer to Section 5.  Device Description for specific information to include in the device 
description for devices of the type covered by this guidance document.)  You should also 
submit an indications for use enclosure.5   
 
Description of device design  
Please include a brief description of the device design requirements. (21 CFR 807.87(f).) 
 
Identification of the risk analysis method 
We recommend that you identify the risk analysis method(s) you used to assess the risk 
profile, in general, as well as the risk profile of the specific devices design and the results 
of this analysis. Please refer to Section 6.  Risks to Health for the risks to health generally 
associated with the use of this device that FDA has identified. 
                                                 
4 An abbreviated 510(k) summary report is intended to explain how a device-specific guidance 
document was used during development and testing of your device.  This is not the 510(k) 
summary described in 21 CFR 807.92, which may be submitted to satisfy 21 CFR 807.87(h). For 
additional information on abbreviated 510(k) summary reports, see section 9 of Format for 
Traditional and Abbreviated 510(k)s at http://www.fda.gov/cdrh/ode/guidance/1567.html. 
5 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
 
3  Contains Nonbinding Recommendations 
 
 
Discussion of the device characteristics  
We recommend that you discuss the device characteristics that address the risks identified 
in this guidance document and any additional risks identified in your risk analysis.   
 
Description of the performance aspects 
We recommend that you include a brief description of the nonclinical tests submitted, 
referenced, or relied on in your submission.  See Sections 7-10 of this guidance for 
specific performance aspects.    If you follow a suggested test method, you may cite the 
method rather than describing it.  If you modify a suggested test method, you may cite the 
method but should provide sufficient information to explain the nature of and reason for 
the modification.  For each test, you may either (1) briefly present the data resulting from 
the test in clear and concise form, such as a table, or (2) describe the acceptance criteria 
that you will apply to your test results.6  (See also 21 CFR 820.30, Subpart C - Design 
Controls for the Quality System Regulation.) 
 
Reliance on standards 
If you choose to rely on a recognized standard for any part of the device design or testing, 
you may include either a:  
 
  statement that testing will be conducted and meet specified acceptance criteria 
before the device is marketed; or  
 
  declaration of conformity to the standard.7   
 
Because a declaration of conformity is based on results from testing, you cannot properly 
submit a declaration of conformity until you have completed the testing the standard 
describes.  For more information, please refer to section 514(c)(1)(B) of the act and the 
FDA guidance, Use of Standards in Substantial Equivalence Determinations.8  
 
If it is not clear how you have addressed the risks identified by FDA or additional risks identified 
through your risk analysis, we may request additional information about aspects of the devices 
performance characteristics.  We may also request additional information if we need it to assess 
                                                 
6 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject 
device should be tested and shown to meet these acceptance criteria before being introduced into 
interstate commerce.  If the finished device does not meet the acceptance criteria and, thus, differs 
from the device described in the cleared 510(k), FDA recommends that submitters apply the same 
criteria used to assess modifications to legally marketed devices (21 CFR 807.81(a)(3)) to 
determine whether marketing of the finished device requires clearance of a new 510(k). 
7 See Required Elements for a Declaration of Conformity to a Recognized Standard 
(Screening Checklist for All Premarket Notification [510(k)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html. 
8 See http://www.fda.gov/cdrh/ode/guidance/1131.html
4  Contains Nonbinding Recommendations 
 
the adequacy of your acceptance criteria.  Under 21 CFR 807.87(l), you must submit any 
additional information that is necessary to reach a determination regarding substantial 
equivalence.  
 
As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 510(k) that 
provides all of the information and data required under 21 CFR 807.87 and described in this 
guidance.  A Traditional 510(k) should include all of your methods, data, acceptance criteria, and 
conclusions.  Manufacturers considering certain modifications to their own cleared devices should 
consider submitting Special 510(k)s.  
 
The following is a specific discussion of how you should apply this guidance document to a 
premarket notification submission for hemodialysis blood tubing sets.  
 
4.  Scope 
The scope of this guidance document is limited to the device described below, 21 CFR 876.5820 
and product codes FJK and KOC.   
 
Section 876.5820  Hemodialysis system and accessories. 
The extracorporeal blood system and accessories consists of tubing, pumps, pressure 
monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the 
blood access device and accessories for hemodialysis ( 876.5540) to the blood compartment 
of the dialyzer and back to the patient. 
 
This generic type of device does not include any tubing or devices used for vascular access, such 
as hemodialysis catheters, or any tubing used for peritoneal dialysis. 
 
5.  Device Description  
You must include the device name (21 CFR 807.87(a)), and you should provide the appropriate 
product code described in Section 4.  You should provide the following information for your 
device:  
  a description of the overall device system; 
  a labeled diagram and the specifications for each model included in the submission, e.g., 
lengths, inner and outer diameters; 
  functionality, including specifications (if applicable) of the individual components of the 
tubing system, e.g., heparin lines, infusion ports, drip chambers, infusion lines, priming 
sets, transducer protectors; and 
  a description, such as might be found in labeling, of the hemodialysis delivery systems 
legally marketed in the United States that are compatible with the blood tubing set. 
 
We recommend that you state whether the arterial and venous lines are sold separately or sold as a 
5  Contains Nonbinding Recommendations 
 
set. 
 
You must also provide a comparison of your device to a legally marketed predicate device. (21 
CFR 807.87(f))  Please provide your comparison in a manner that is clear and comprehensible, 
e.g., in tabular form listing the similarities and differences between the proposed and predicate 
device in terms of intended use, design features, performance specifications, and other important 
safety and effectiveness information.  We recommend you compare the blood tubing and any 
accessories, e.g., clamps, connectors, transducer protectors, between your device and the 
predicate device. 
 
We recommend you include the following information when comparing your device and the 
marketed predicate device. 
  indications for use; 
  materials; 
  biocompatibility;  
  design specifications; and  
  performance specifications.  
 
6.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with the use of the 
device addressed in this document.  The measures recommended to mitigate these identified risks 
are given in this guidance document, as shown in the table below.  We recommend that you also 
conduct a risk analysis, before submitting your 510(k), to identify any other risks specific to your 
device and include the results of this analysis.  If you elect to use an alternative approach to 
address a particular risk identified in this document, or have identified risks additional to those in 
this document, then you should provide sufficient detail to support the approach you have used to 
address that risk. 
 
Identified Risk  Recommended Mitigation Measures 
Device malfunction  Section 7. Performance Testing 
Section 10. Expiration Date Testing 
Potential infection  Section 9. Sterility 
Adverse tissue reaction  Section 8. Biocompatibility Testing 
Improper use  Section 11. Labeling 
Pyrogen reaction  Section 9. Sterility 
6  Contains Nonbinding Recommendations 
 
Hemolysis  Section 7. Performance Testing 
Section 10. Expiration Date Testing 
Air embolism  Section 7. Performance Testing 
Section 10. Expiration Date Testing 
Blood loss  Section 7. Performance Testing 
Section 10. Expiration Date Testing 
 
7.  Performance Testing 
You should describe the performance characteristics of the blood tubing set and include 
functional testing demonstrating the device performs as you describe. Please compare the results 
of performance testing data to results obtained for the predicate device. (21 CFR 807.87(f))  If 
your device performance range falls outside of the range for the predicate device, explain why 
this difference does not affect the safety or effectiveness, and therefore, the substantial 
equivalence of your device. 
 
We recommend you perform the following tests on three or more hemodialysis tubing sets of each 
model you intended to market: 
  pressure leak testing demonstrating that the blood tubing can withstand pressures up to 1.5 
times the maximum labeled positive and negative pressures; 
  endurance testing of the pump segment at maximum labeled blood flow rates and 
pressures; 
  endurance testing, under both positive and negative pressures, of any injection ports (if 
applicable), using the largest recommended gauge needle identified in the labeling; 
  priming volume assessment; 
  tensile testing of joints and materials of all tubing segments; 
  the ability of pressure transducers to withstand leakage when subjected to pressures up to 
2 times the maximum labeled pressure, e.g., strikethrough 
  performance testing of the devices clamps to demonstrate that they can successfully 
occlude the blood tubing; 
  hemocompatibility (i.e., mechanical hemolysis) for a new or significantly altered 
hemodialysis tubing design that affects the pattern of blood flow; and 
  performance testing to evaluate the ability of the tubing to resist kinking after repeated 
clamping, particularly in the post-pump tubing segment.   
 
We also recommend you evaluate a blood tubing set on each hemodialysis delivery system(s) 
specified in your labeling and operators manual by operating the unit with a blood analog fluid 
7  Contains Nonbinding Recommendations 
 
for four hours at 37 C to demonstrate that tubing failure (i.e., tube kinking) does not occur.  
During this testing, we recommend that you inspect the tubing for kinks caused by excessive or 
undersized tubing, across the length of the tubing, using a variety of hemodialyzer sizes.  We also 
recommend that you validate the diameter of the blood pump segment to ensure that the correct 
blood volume is being pumped by the hemodialysis delivery system.  . 
 
8.  Device Materials and Biocompatibility 
Please describe the materials used to fabricate all components of the hemodialysis tubing set 
(807.87(f)), including any colorants (e.g., inks, dyes, markings), plasticizers (including di-(2-
Ethylhexyl) phthalate or DEHP) or additives.  We recommend you group these materials 
according to whether they have direct or indirect contact with the circulating blood.  For each of 
these materials, we recommend you: 
  identify a current, legally marketed device that uses the identical materials and 
manufacturing methods for a similar intended use; or 
  provide appropriate biocompatibility testing on a finished, sterilized device such as the 
testing recommended in the current FDA guidance on biocompatibility testing, Office of 
Device Evaluation (ODE) Blue Book memorandum, G95-1 "Use of International 
Standard ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and 
Testing".  
 
Hemodialysis blood tubing sets are considered externally communicating devices, contacting 
circulating blood, prolonged contact Class II (Category B).  If you are unable to identify a legally 
marketed predicate device that uses the exact materials as described above, we recommend you 
conduct the following tests:   
  cytotoxicity; 
  sensitization (Guinea pig maximization with polar and non-polar extracts); 
  irritation or intracutaneous reactivity; 
  acute systemic toxicity; 
  hemocompatibility, e.g., chemical and mechanical hemolysis; and 
  genotoxicity. 
 
Alternatively, you may provide a justification for not conducting any of the tests identified above. 
 
9.  Sterility 
FDA recommends that you provide sterilization information, such as that described in the 
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and 
FDA9.  We recommend the device be sterile with a sterility assurance level (SAL) of 1 x 10-6.  
 
                                                 
9 http://www.fda.gov/cdrh/ode/guidance/361.html. 
8  Contains Nonbinding Recommendations 
 
Blood tubing sets are in contact with circulating blood; therefore, we recommend you test the 
devices for pyrogenicity.  We recommend you provide a: 
 
  description of the method used to make the determination, e.g., limulus amebocyte 
lysate (LAL); 
  identification of the testing endpoint reached and rationale for selecting that endpoint;  
  description of the extraction technique used to obtain the test fluid from the test 
device, showing that all clinically relevant contact surfaces of the test device were 
assessed; and 
  identification of the reference method used, e.g., United States Pharmacopoeia (USP), 
ANSI/AAMI ST 72:2002, Bacterial endotoxins - Test methodologies, routine 
monitoring, and alternatives to batch testing or FDA guidance.   
 
10.  Expiration Date Testing 
We recommend all labels for hemodialysis blood tubing include an expiration date.  We 
recommend you provide the following tests to substantiate the validity of the proposed expiration 
date on devices subjected to real-time or accelerated aging: 
  biocompatibility testing of hemodialysis blood tubing sets including all testing described 
in Section 8. Device Materials and Biocompatibility;  
  performance testing on aged samples including the testing listed in Section 7. 
Performance Testing; and 
  package integrity testing to demonstrate sterility and non-pyrogenicity. 
 
Accelerated conditions may be used to support the labeled expiration date, as long as you include 
an adequate scientific rationale supporting your accelerated testing.  In addition, we recommend 
you initiate real-time testing when you submit your 510(k) and include the real-time results in 
your device master record.   
 
11.  Labeling  
The premarket notification must include labeling in sufficient detail to satisfy the requirements of 
21 CFR 807.87(e).  The following suggestions are intended to assist you in preparing labeling that 
satisfies the requirements of 21 CFR Part 801.10
 
                                                 
10 Although final labeling is not required for 510(k) clearance, final labeling must comply with 
the requirements of 21 CFR Part 801 before a medical device is introduced into interstate 
commerce.  In addition, final labeling for prescription medical devices must comply with 21 CFR 
801.109.  Labeling recommendations in this guidance are consistent with the requirements of Part 
801. 
9  Contains Nonbinding Recommendations 
 
A.  Directions for Use 
As a prescription device under 21 CFR 801.109, the device is exempt from having 
adequate directions for lay use.  Nevertheless, you must adequate information for use, 
including indications, effects, routes, methods, and frequency and duration of use and any 
relevant hazards, contraindications, side effects, and precautions. (801.109(d))   
Instructions should encourage local and institutional training programs designed to 
familiarize users with the features of the device and how to use it in a safe and effective 
manner.   
 
B.  Intended Use 
You must state the intended use of your device and include the indications for use and the 
intended (target) population (e.g., pediatric patients). (801.109(c)) 
 
C.  Description of the Device 
We recommend the description of the device include: 
  identification of the components in the package, e.g., arterial tubing, venous 
tubing, priming set; 
  total length of the arterial and venous tubing sets; 
  outer diameter (OD) of the pump segment; 
  priming volume; 
  identification of the hemodialysis delivery systems which are compatible with the 
blood tubing set; 
  identification of the largest gauge needle that can be used with the injection port (if 
applicable); 
  identification of the maximum operating pressures for the transducer protectors; 
  a statement that the device is for single use only, and has a nontoxic and non-
pyrogenic fluid path; 
  a statement that the package is sterile, if the package is intact and undamaged, and 
protective caps are secure. 
 
We also recommend you color code the device so that the patient and dialyzer 
connectors of the arterial blood tubing are red and the patient and dialyzer connectors 
of the venous blood tubing are blue.   
 
D.  Warnings 
You must include a warning that significant hemolysis of red blood cells can occur in 
kinked blood tubing, especially in the post-pump, arterial tubing segment.  (801.109(d))  
10  Contains Nonbinding Recommendations 
 
As a precaution, you must include a warning indicating that the device is intended for 
single use only. 
 
E.  Outer Package Labeling 
In addition to the requirements of 21 CFR 801, we recommend that the outer package 
labeling include: 
  device name; 
  U.S. point of contact; 
  storage conditions; 
  priming volume; 
  sterility status and method; 
  sterilization date; 
  a non-pyrogenic statement; 
  lot number; and  
  expiration date. 
 
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Appendix I.  Glossary of Terms 
The terms here are defined for the purpose of this guidance document only, unless otherwise 
noted. 
 
Arterial blood tubing.  The portion of the tubing set that transports blood from the patient to the 
hemodialyzer inlet port. 
 
Conventional hemodialysis delivery device.  Under 21 CFR 876.5820(a)(3), a conventional 
hemodialysis delivery system is defined as a system that ...consists of mechanisms that monitor 
and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates 
dialysate through the dialysate compartment of the dialyzer.  The dialysate delivery system 
includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate 
abnormal dialysate conditions. 
 
High permeability hemodialysis delivery device.  Under 21 CFR 876.5860(a)(2), a high 
permeability hemodialysis delivery system is defined as a machine that ...is similar to the 
extracorporeal blood system and dialysate delivery system of the hemodialysis system and 
accessories (21 CFR 876.5820), with the addition of an ultrafiltration controller and mechanisms 
that monitor and/or control such parameters as fluid balance, dialysate composition, and patient 
treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).  
 
Infusion port.  A component of hemodialysis blood tubing allowing the injection of fluids 
through a septum. 
 
Priming set.  A segment of tubing specifically designed to prime the hemodialysis blood tubing. 
 
Pump segment.  The portion of the tubing upon which a peristaltic or rotary hemodialysis 
delivery pump acts. 
 
Sorbent regenerated dialysate delivery system.  Under 21 CFR 876.5600(a), A sorbent 
regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial 
kidney system for the treatment of patients with renal failure or toxemic conditions, and that 
consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the 
dialysate compartment of the dialyzer.  The device is used with the extracorporeal blood system 
and the dialyzer of the hemodialysis system and accessories (876.5820).  The device includes the 
means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the 
dialysate, and alarms to indicate abnormal dialysate conditions.  The sorbent cartridge may 
include absorbent, ion exchange and catalytic materials.  
 
Transducer protector.  A component of hemodialysis blood tubing with a hydrophobic 
membrane designed to prevent blood contamination of the pressure transducers of a hemodialysis 
delivery system. 
 
Venous blood tubing.  The portion of the tubing set that transports blood from the hemodialyzer 
outlet port back to the patient. 
 
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