ATTACHMENT B

**[ADVISORY LIST OF HIGH RISK DEVICES\*]{.underline}**

**[THAT ARE INTENDED FOR SURGICAL IMPLANT OR SUSTAINING
LIFE]{.underline}**

ANESTHESIOLOGY DEVICES Page 2

CARDIOVASCULAR DEVICES Page 3

DENTAL DEVICES Page 6

EAR, NOSE, AND THROAT DEVICES Page 6

GASTROENTEROLOGY-UROLOGY DEVICES Page 6

GENERAL AND PLASTIC SURGERY DEVICES Page 8

GENERAL HOSPITAL AND PERSONAL USE DEVICES Page 8

NEUROLOGICAL DEVICES Page 9

OBSTETRICAL AND GYNECOLOGICAL DEVICES Page 11

OPHTHALMIC DEVICES Page 11

ORTHOPEDIC DEVICES Page 11

\*SUPPLEMENTAL INFORMATION (#)

Dialysis Systems & Accessories

Peritoneal Dialysis Systems and Accessories Page 17

Hemodialysis Systems and Accessories Page 18

\*High Risk Devices are Class III and Class II devices that are
life-sustaining/life-supporting devices (based on the Advisory List of
Critical Devices -- Federal Register, March 17, 1988) or significant
risk devices, as defined by 21 CFR 812.3(m) for Investigational Devices
Exemptions.

NOTE: The Quality System Regulation no longer refers to critical
devices. However, 21 CFR 820.65 requires traceability for all devices
that meet the same definition as devices on the Advisory List of
Critical Devices - 1988.

**PART 868 \-- ANESTHESIOLOGY DEVICES**

Device

No. on

CFR or Classification Name Original Former device name, or

FR Cite of Device List Additional Information

1\. 868.1200 Indwelling blood oxygen 5 Analyzer, oxygen,

partial pressure (P~02~) Neonatal Invasive

analyzer.

2\. 868.2375 Breathing frequency \-- Apnea monitor.

monitor.

3\. 868.5090 Emergency airway needle. 43 Needle, emergency airway.

4\. 868.5160(a) Gas machine for anes- 42 Machine, gas anesthesia/

thesia analgesia, complete systems. Section 868. 5160(b) Gas

machine for analgesia is exempt

from critical device requirements.

5\. 868.5240 Anesthesia breathing 19 Circuit, breathing (w/

circuit. connector, adaptor y-piece).

6\. 868.5400 Electroanesthesia 6,62 Apparatus, electroanesthesia;

apparatus. and stimulator, electroanesthesia.

7\. 868.5440 Portable oxygen 32 Generator, oxygen,

generator. portable. #See Pg 25

8\. 868.5470 Hyperbaric chamber. \-- \-\--

(Monoplace)

9\. 868.5610 Membrane lung for long- 41 Lung, membrane (for long-term

term pulmonary support. pulmonary support).

10\. 868.5650 Esophageal obturator. 2 Airway, esophageal (obturator).

11\. 868.5720 Bronchial tube. 66 Tube, bronchial (w/wo

connector).

12\. 868.5730 Tracheal tube. 67 Tube, tracheal (w/wo connector).

13\. 868.5740 Tracheal/bronchial 68 Tube, tracheal/bronchial,

differential ventila- differential/ventilation

tion tube. (w/wo connector).

14\. 868.5750 Inflatable tracheal 27 Cuff, tracheal tube, inflatable.

tube cuff.

15\. 868.5800 Tracheostomy tube and 69 Tube, tracheostomy

tube cuff. (w/wo connector).

16\. 868.5810 Airway connector. 25 Connector, airway (extension).

17\. 868.5830 Autotransfusion apparatus. 9 Autotransfusion apparatus.

18\. 868.5895 Continuous ventilator. 73,56 Ventilator, continuous
(respirator)

and respirator, neonatal ventilator

19\. 868.5905 Noncontinuous 75 Ventilator, noncontinuous

ventilator (IPPB). (respirator).

20\. 868.5915 Manual emergency 58,70 Manual emergency ventilator;

ventilator. and resuscitator, pulmonary, manual.

21\. 868.5925 Powered emergency 70 Unit emergency oxygen and

ventilator. resuscitation.

22\. 868.5935 External negative 74 Ventilator, external body negative

pressure ventilator. pressure, adult (cuirass).

**PART 870 - CARDIOVASCULAR DEVICES**

23\. 870.1025 Arrhythmia detector 29 Detector and alarm,

and alarm. arrhythmia.

24\. 870.1330 Catheter guide wire. \-- For use with percutaneous

transluminal coronary angioplasty

catheters. (See #56.)

25\. 870.1360 Trace microsphere. \-- \-\--

26\. 870.1750 External programmable 34 Generator, pulse, pace-

pacemaker pulse maker, external,

generator. programmable.

27\. 870.1800 Withdrawal-infusion 54 Pump, withdrawal/

pump. infusion.

28\. 870.3250 Vascular clip. 22 Clip, vascular.

29\. 870.3260 Vena cava clip. 23 Clip, vena cava.

30\. 870.3300 Arterial embolization \-- \-\--

device.

31\. 870.3375 Cardiovascular 31 Filter, intravascular,

intravascular filter. cardiovascular

32\. 870.3450 Vascular graft 47,52 Prosthesis, arterial graft

prosthesis of less than synthetic, and prosthesis

6-millimeters diameter. vascular graft.

33\. 870.3460 Vascular graft 47,52 Prosthesis, arterial graft

prosthesis of 6 milli- synthetic, and prosthesis,

meters and greater diameter. vascular graft.

34\. 870.3470 Intracardiac patch or \-- \-\--

pledget made of poly-

propylene, polyethylene

polyethylene tere-

phthalate, or polytetra-

fluoroethylene.

35\. 870.3535 Intra-aortic balloon and 10 Balloon, intra-aortic,

control system. and control system.

36\. 870.3545 Ventricular bypass 15 Bypass, ventricular

(assist) device. (assist).

37\. 870.3600 External pacemaker 33 Generator, pulse,

Pulse generator. pacemaker, external.

38\. 870.3610 Implantable pacemaker 35 Generator, pulse, pace-

pulse generator. maker, implantable.

39\. 870.3620 Pacemaker lead adaptor. \-- \-\--

40\. 870.3650 Pacemaker polymeric \-- \-\--

mesh bag.

41\. 870.3670 Pacemaker charger. \-- \-\--

42\. 870.3680 Cardiovascular permanent 30 Electrode, pacemaker,

or temporary pacemaker, permanent and temporary

electrode.

43\. 87O.3700 Pacemaker programmers. \-- \-\--

44\. 870.3710 Pacemaker repair or \-- \-\--

replacement material.

45\. 870.3800 Annuloplasty ring. \-- \-\--

46\. 870.3850 Carotid sinus nerve \-- \-\--

stimulator.

47\. 870.3925 Replacement heart valve. 71 Valve, heart replacement.

48\. 870.4320 Cardiopulmonary \-- \-\--

bypass pulsatile flow

generator.

49\. 870.4350 Cardiopulmonary 44 Oxygenator, cardiopulmonary.

bypass oxygenator.

50\. 870.4360 Nonroller-type 13 Blood pump, cardiopulmonary

cardiopulmonary bypass bypass, non-roller.

blood pump.

51\. 870.4370 Roller-type 14 Blood pump, cardiopulmonary

cardiopulmonary bypass roller type.

bypass blood pump.

52\. 870.5200 External cardiac 24,57 Compressor, external, cardiac

compressor. powered, and resuscitator, cardiac

mechanical.

53\. 870.5225 External counter- 26 Counter-pulsating device,

pulsating device. external.

54\. 870.5300 DC-defibrillator 28 Defibrillator, DC-powered

(including paddles). (including paddles).

55\. 870.5550 External transcutaneous 45 Pacemaker, cardiac, external

cardiac pacemaker transcutaneous.

(noninvasive).

56\. \-\-- Percutaneous transluminal \-- Premarket approval device.

coronary angioplasty

(PTCA) balloon dilation

catheter.

57\. \-\-- Automatic Implanted \-- Premarket approval device.

Cardioverter Defibril-

lator System.

**PART 872 \-- DENTAL DEVICES**

58\. 872.3640 Endosseous implant. \-- \-\--

**PART 874 \-- EAR, NOSE, AND THROAT DEVICES**

59\. 874.3620 Ear, nose and throat \-- \-\--

synthetic polymer

material.

60\. 874.3695 Mandibular implant \-- \-\--

facial prosthesis.

61\. 874.3730 Laryngeal prosthesis 49 Prosthesis, Laryngeal

(Taub design).

62\. 874.3820 Endolymphatic shunt \-- \-\--

63\. 874.3850 Endolymphatic shunt tube \-- \-\--

with valve.

64\. 874.3930 Tympanostomy tube with \-- \-\--

semipermeable membrane

65\. \-\-- Ear, nose, throat natural \-- Pre-Amendments Device;

polymer - collagen not classified.

material.

**PART 876 \-- GASTROENTEROLOGY-UROLOGY DEVICES**

66\. 876.3350 Penile inflatable implant. \-- \-\--

66a 876.3630 Penile rigidity implant \-- \-\--

67\. 876.5270 Implanted electrical \-- \-\--

urinary continence

device.

68\. 876.5540 A-V shunt cannula. \-- Included in blood access

device and accessories.

69\. 876.5630 \# Peritoneal dialysis 46 Peritoneal dialysis system,

system and accessories. automatic delivery

70\. 876.5820 \# Hemodialysis system and 36 Dialysate concentrate added.

and accessories.

Dialysate concentrate

Hollow fiber capillary

dialyzers Disposable dialyzers

High permeability dialyzers

Parallel flow dialyzers

Single needle dialysis set

Dialysate delivery system

**\# See charts showing the critical/noncritical breakdown of peritoneal
and hemodialysis systems on pages 17 and 18 of Attachment B.**

70A 876.5860 \# High permeability Dialysate concentrate added.

hemodialysis system. 36

71\. 876.5870 Sorbent hemoperfusion 7 Apparatus, hemoperfusion,

system. sorbent.

72\. 876.5880 Isolated kidney perfusion \-- \-\--

and transport system

and accessories.

73\. 876.5955 Peritoneo-venous shunt. \-- \-\--

74\. 46 FR 7566 Urethral sphincter 51 Prosthesis, urethra sphincter;

(1/23-/81) prosthesis. device-not known to be in

commercial distribution.

75\. 46 FR 7566 Urethral replacement 55 Replacement, urethral.

(1/23/81) Device not known to be

in commercial distribution.

**PART 878 \-- GENERAL AND PLASTIC SURGERY DEVICES**

(The following are class III devices. See 21 U.S.C. 360j(l).)

76\. 42 FR 63474 Absorbable surgical \-- Class III transitional

(12/16/77) sutures. device.

77\. 42 FR 63474 Nonabsorbable surgical \-- Class III transitional

(12/16/77) sutures. device.

78\. 879.4520 Polytetrafluoroethylene \-- Class III transitional

(Teflon) injectable. device.

79\. 878.3300 Surgical mesh. \-- \-\--

80\. 878.3500 Polytetrafluoroethylene \-- \-\--

with carbon fibers

composite implant material.

81\. 878.3530 Inflatable breast \-- \-\--

prosthesis

82\. 878.3540 Silicone gel-filled breast \-- \-\--

prosthesis.

83\. \-\-- Implanted mammary 510(k) device.

prosthesis of composite

saline and gel-filled

design.

84\. 878.3610 Esophageal prosthesis. 48 Prosthesis, esophagus.

85\. 878.3720 Tracheal prosthesis. 50 Prosthesis, trachea.

86\. 878.4300 Implantable clip. \-- \-\--

87\. 878.4750 Implantable staple. \-- \-\--

88\. \-\-- Maxillofacial prosthesis. \-- ENT facial prosthesis,
maxillofacial.

**PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES**

89\. 880.5130 Infant radiant warmer. 12 Bed, radiant heat.

90\. 880.5400 Neonatal incubator. 37 Incubator, neonatal ventilator.

91\. 880.5410 Neonatal transport \-- \-\--

incubator.

92\. 880.5725 Infusion pump. 53 Term \"cardiovascular\" dropped since

not used in classification regulation

and devices not marketed as

\"cardiovascular infusion pumps.\"

93\. \-- Implanted infusion pump. \-- Premarket approval device.

**PART 882 - NEUROLOGICAL DEVICES**

94\. 882.5030 Methyl methacrylate for \-- \-\--

aneurysmorrhaphy.

95\. 882.5150 Intravascular occluding 17 Catheter, intravascular

catheter. occluding.

96\. 882.5200 Aneurysm clip. 20 Clip, aneurysm.

97\. 882.5225 Implanted malleable clip. \-- \-\--

98\. 882.5250 Burr hole cover. \-- \-\--

99\. 882.5300 Methyl methacrylate for \-- \-\--

cranioplasty.

100\. 882.5320 Preformed alterable \-- \-\--

cranioplasty plate.

101\. 882.5330 Preformed nonalterable \-- \-\--

cranioplasty plate.

102\. 882.5360 Cranioplasty plate fastener. \-- \-\--

103\. 882.5550 Central nervous system 59 Shunt, central nervous

fluid shunt and components. system fluid and components.

104\. 882.5820 Implanted cerebellar 60 Stimulator, cerebella,

stimulator. implanted.

105\. 882.5830 Implanted diaphragmatic/ 61 Stimulator, diaphragmatic/

phrenic nerve stimulator. phrenic nerve, implanted.

106\. 882.5840 Implanted intracerebral/ 63 Stimulator, intracerebral/

subcortical stimulator subcortical, implanted

for pain relief. (pain relief).

107\. 882.5850 Implanted spinal cord \-- \-\--

stimulator for bladder

evacuation.

108\. 882.5860 Implanted neuromuscular \-- \-\--

stimulator.

109\. 882.5870 Implanted peripheral nerve \-- \-\--

stimulator for pain

relief.

110\. 882.5880 Implanted spinal cord \-- \-\--

stimulator for pain

relief.

111\. 882.5880 Epidural spinal electrode. \-- Component of Implanted
spinal cord

stimulator for pain relief (#110).

112\. 882.5900 Preformed craniosynostosis \-- \-\--

strip.

113\. 882.5910 Dura substitute. \-- \-\--

114\. 882.5950 Artificial embolization 65 Thromboemboli, intravascular

device. (artificial embolization device).

115\. \-\-- Lyophilized human \-- Pre-Amendments device;

(cadaver) dura mater. not classified.

116\. \-\-- Stabilized epidural spinal \-- Premarket approval

electrode. device.

117\. \-\-- Implanted intracranial \-- Premarket approval

pressure monitor. device.

118\. \-\-- Totally implanted spinal \-- Premarket approval

cord stimulator for pain device.

relief.

**PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES**

119\. 884.5360 Contraceptive intrauterine 38 Intrauterine contraceptive

device (IUD) and intro- device (IUD) and introducer.

ducer.

120\. 884.5380 Contraceptive tubal 11 Band, tubal occlusion;

occlusion device (TOD) 21 Clip, tubal Occlusion;

and introducer. 72 Valve, tubal occlusion.

**PART 886 - OPHTHALMIC DEVICES**

121\. 886.3300 Absorbable implant \-- \-\--

(scleral buckling method)

122\. 886.3400 Keratoprosthesis 39 Keratoprosthesis, non-custom

123\. 886.3600 Intraocular lens 40 Lens, intraocular, ophthalmic;

Class III transitional device.

124\. 886.3920 Eye valve implant \-- \-\--

**PART 888 ORTHOPEDIC DEVICES**

125\. 888.3000 Bone Cap. \-- \-\--

126\. 888.3010 Bone fixation cerclage. \-- \-\--

127\. 888.3020 Intramedullary fixation \-- \-\--

rod.

128\. 888.3025 Passive tendon prosthesis. \-- \-\--

129\. 888.3027 Polymethylmethacrylate \-- Class III transitional (PMMA)
bone cement. device.

130\. 888.3030 Single/multiple component \-- \-\--

metallic bone fixation

appliances and acces­-

sories.

131\. 888.3040 Smooth or threaded \-- \-\--

metallic bone fixation

fastener.

132\. 888.3050 Spinal interlaminal \-- \-\--

fixation orthosis.

133\. 888.3060 Spinal intervertebral body \-- \-\--

fixation orthosis.

134\. 888.3100 Ankle joint metal/composite \-- \-\--

semi-constrained

cemented prosthesis.

135\. 888.3110 Ankle joint metal/polymer \-- \-\--

semi-constrained

cemented prosthesis.

136\. 888.3120 Ankle joint metal/polymer \-- \-\--

non-constrained

cemented prosthesis.

137\. 888.3150 Elbow joint metal/metal or \-- \-\--

metal/polymer constrained

cemented prosthesis.

138\. 888.3160 Elbow joint metal/polymer \-- \-\--

semi-constrained

cemented prosthesis.

139\. 888.3170 Elbow joint radial (hemi- \-- \-\--

elbow) polymer prosthesis.

140\. 888.3180 Elbow joint humeral (hemi- \-- \-\--

elbow) metallic

uncemented prosthesis.

141\. 888.3200 Finger joint metal/metal \-- \-\--

constrained uncemented

prosthesis.

142\. 888.3210 Finger joint metal/metal \-- \-\--

constrained cemented

prosthesis.

143\. 888.3220 Finger joint metal/polymer \-- \-\--

constrained cemented

prosthesis.

144\. 888.3230 Finger joint polymer con- \-- \-\--

strained prosthesis.

145\. 888.3300 Hip joint metal constrained \-- \-\--

cemented or uncemented

prosthesis.

146\. 888.3310 Hip joint metal/polymer \-- \-\--

constrained cemented or

uncemented prosthesis.

147\. 888.3320 Hip joint metal/metal \-- \-\--

semi-constrained, with a

cemented acetabular

component, prosthesis.

148\. 888.3330 Hip joint metal/metal \-- \-\--

semi-constrained, with

an uncemented acetabular

component, prosthesis.

149\. 888.3340 Hip joint metal/composite \-- \-\--

semi-constrained

cemented prosthesis.

150\. 888.3350 Hip joint metal/polymer \-- \-\--

semi-constrained

cemented prosthesis.

151\. 888.3360 Hip joint femoral (hemi- \-- \-\--

hip) metallic cemented

or uncemented prosthesis.

152\. 888.3370 Hip joint (hemi-hip) \-- \-\--

acetabular metal

cemented prosthesis.

153\. 888.3380 Hip joint femoral (hemi- \-- \-\--

hip) trunnion-bearing

metal/polyacetal

cemented prosthesis.

154\. 888.3390 Hip joint femoral (hemi-hip) \-- \-\--

metal/polymer cemented

or uncemented prosthesis.

155\. 888.3400 Hip joint femoral (hemi- \-- \-\--

hip) metallic resurfacing

prosthesis.

156\. 888.3410 Hip joint metal/polymer \-- \-\--

semi-constrained resur-

facing cemented

prosthesis.

157\. 888.3480 Knee joint femorotibial \-- \-\--

metallic constrained

cemented prosthesis.

158\. 888.3490 Knee joint femorotibial \-- \-\--

metal/composite non-

constrained cemented

prosthesis.

159\. 888.3500 Knee joint femorotibial \-- \-\--

metal/composite semi-

constrained cemented

prosthesis.

160\. 888.3510 Knee joint femorotibial \-- \-\--

metal/polymer con-

strained cemented

prosthesis.

161\. 888.3520 Knee joint femorotibial \-- \-\--

metal/polymer non-

constrained cemented

prosthesis.

162\. 888.3530 Knee joint femorotibial \-- \-\--

metal/polymer semi-

constrained cemented

prosthesis.

163\. 888.3540 Knee joint patellofemoral \-- \-\--

polymer/metal semi-

constrained cemented

prosthesis.

164\. 888.3550 Knee joint patellofemoro- \-- \-\--

tibial polymer/metal/

metal constrained

cemented prosthesis.

165\. 888.3560 Knee joint patellofemoro- \-- \-\--

tibial polymer/metal/

polymer semi-constrained

cemented prosthesis.

166\. 888.3570 Knee joint femoral (hemi- \-- \-\--

knee) metallic

uncemented prosthesis.

167\. 888.3580 Knee joint patellar (hemi- \-- \-\--

knee) metallic resur-

facing uncemented

prosthesis.

168\. 888.3590 Knee joint tibial (hemi- \-- \-\--

knee) metallic resur-

facing uncemented

prosthesis.

169\. 888.3640 Shoulder joint metal/metal \-- \-\--

or metal/polymer con­strained

cemented prosthesis.

170\. 888.3650 Shoulder joint metal/ \-- \-\--

polymer non-constrained

cemented prosthesis.

171\. 888.3660 Shoulder joint metal/ \-- \-\--

polymer semi-constrained

cemented prosthesis.

172\. 888.3680 Shoulder Joint glenoid \-- \-\--

(hemi- shoulder) metallic

cemented prosthesis.

173\. 888.3690 Shoulder joint humeral \-- \-\--

(hemi- shoulder) metallic

uncemented prosthesis.

174\. 888.3720 Toe joint polymer con- \-- \-\--

strained prosthesis.

175\. 888.3730 Toe joint phalangeal \-- \-\--

(hemi-toe) polymer

prosthesis.

176\. 888.3750 Wrist joint carpal lunate \-- \-\--

polymer prosthesis.

177\. 888.3760 Wrist joint carpal scaphoid \-- \-\--

Polymer prosthesis.

178\. 888.3770 Wrist joint carpal trape- \-- \-\--

zium polymer prosthesis.

179\. 888.3780 Wrist joint polymer con- \-- \-\--

strained prosthesis.

180\. 888.3790 Wrist joint metal con- \-- \-\--

strained cemented prosthesis.

181\. 888.3800 Wrist joint metal/polymer \-- \-\--

semi-constrained cemented

prosthesis.

182\. 888.3810 Wrist joint ulnar (hemi- \-- \-\--

wrist) polymer prosthesis.

**[PERITONEAL DIALYSIS SYSTEMS AND ACCESSORIES]{.underline}**

+-------------------+--------------------+-------------------+----+---+
| INDIVIDUAL DEVICE | COMPONENT          | ACCESSORY         | CR |   |
|                   |                    |                   | IT |   |
|                   |                    |                   | IC |   |
|                   |                    |                   | AL |   |
+-------------------+--------------------+-------------------+----+---+
|                   |                    |                   | Y  | N |
|                   |                    |                   | ES | O |
+-------------------+--------------------+-------------------+----+---+
| Semi-auto         |                    |                   | X  |   |
| Peritoneal        |                    |                   |    |   |
|                   |                    |                   |    |   |
| Dialysis System   |                    |                   |    |   |
+-------------------+--------------------+-------------------+----+---+
| Auto. Peritoneal  |                    |                   | X  |   |
| Dialysis System   |                    |                   |    |   |
+-------------------+--------------------+-------------------+----+---+
| Single-Use        |                    |                   | X  |   |
| Peritoneal        |                    |                   |    |   |
| Catheter          |                    |                   |    |   |
+-------------------+--------------------+-------------------+----+---+
| Long-Term         |                    |                   | X  |   |
| Peritoneal        |                    |                   |    |   |
| Catheter          |                    |                   |    |   |
+-------------------+--------------------+-------------------+----+---+
|                   |                    | Stylet            |    | X |
+-------------------+--------------------+-------------------+----+---+
|                   |                    | Trocar            |    | X |
+-------------------+--------------------+-------------------+----+---+
|                   |                    | Obturator         |    | X |
+-------------------+--------------------+-------------------+----+---+
|                   |                    | Disposable        | X  |   |
|                   |                    | Administration    |    |   |
|                   |                    | Set               |    |   |
+-------------------+--------------------+-------------------+----+---+
|                   |                    | Peritoneal        |    | X |
|                   |                    | Dialysate Filter  |    |   |
+-------------------+--------------------+-------------------+----+---+

As of this time, the following peritoneal dialysate products are
considered drugs and are registered by the CDER: sterile prepackaged
dialysate and dialysate solutions for peritoneal dialysis.

**[HEMODIALYSIS SYSTEMS AND ACCESSORIES]{.underline}**

  ------------------- --------------------- ------------------- ---------- ----
  INDIVIDUAL DEVICE   COMPONENT             ACCESSORY           CRITICAL   

                                                                YES        NO

  Conventional                                                  X          
  Dialyzer                                                                 

  Dialysate Delivery                                            X          

                      Water Purification                        X          
                      System                                               

                      Monitor & Control                         X          
                      Mechanisms                                           

                      Alarms                                    X          

                                            Unpowered HD Chair             X
                                            w/o Scale                      

                                            Powered HD Chair               X
                                            w/o Scale                      

                                            Dialyzer Holder Set            X

                                            Dialysis Tie Gun &             X
                                            Ties                           

                                            Hemodialysis                   X
                                            Start/Stop Tray                

                                            Hemodialysis        X          
                                            Concentrate                    

  Extracorporeal                                                X          
  Blood System                                                             

                      Tubing                                    X          

                      Pumps                                     X          

                      Pressure Monitors                         X          

                      Air Foam or Bubble                        X          
                      Detectors                                            

                      Alarms                                    X          
  ------------------- --------------------- ------------------- ---------- ----

\* Water purification systems when part of the dialysis delivery system.