Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=39152
Timestamp: 2019-12-12 01:19:26
Document Index: 613623256

Matched Legal Cases: ['art 3', '§876', '§876', '§876', '§876', '§876', '§876', '§876', '§876', '§876', '§876']

FR Recognition List Number 045 Date of Recognition 09/21/2016
FR Recognition Number 5-109
ISO 80369-3 First Edition 2016-07-01
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications.
FDA recognition of ISO 80369-3 First Edition 2016-07-01 [Rec# 5-109] will be superseded by recognition of ISO 80369-3 First Edition 2016-07-01 [Including AMENDMENT 1 (2019)]. [Rec# 5-123]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 5-109] until July 26, 2020. After this transition period, declarations of conformity to [Rec # 5-109] will not be accepted.
§876.5980 Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Enteral Syringes With Enteral Specific Connectors Class 2 PNR
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tube, Nasogastric Class 2 BSS
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, Issued on February 11, 2015
(Website) Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tubingandluermisconnections/ucm313322.htm
FDA/OMPT/CDRH/ODE/
301-796-5155
joshua.silverstein@fda.hhs.gov
General I (QS/RM)