Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

031

Date of Entry 08/06/2013

FR Recognition Number

9-31

Standard

ANSI AAMI ID54:1996/(R)2012
Enteral feeding set adapters and connectors

Scope/Abstract

This standard specifies safety requirements for enteral feeding set connectors and adapters.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§876.5980	Bag, Hemostatic	Class 2	FCB
§876.5980	Balloon, Liver Tamponade	Class 2	NGU
§876.5980	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration	Class 2	KDH
§876.5980	Catheter, Rectal	Class 2	GBT
§876.5980	Catheter, Retention Type	Class 2	EZK
§876.5980	Catheter, Retention, Barium Enema With Bag	Class 2	FGD
§876.5980	Intestinal Splinting Tubes	Class 2	LCG
§876.5980	Set, Gavage, Infant, Sterile	Class 2	FHT
§876.5980	String And Tubes, Gastrointestinal, To Locate Internal Bleeding	Class 2	FFW
§876.5980	Tray, Irrigation, Sterile	Class 2	EYN
§876.5980	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Class 2	FEG
§876.5980	Tube, Feeding	Class 2	FPD
§876.5980	Tube, Gastro-Enterostomy	Class 2	KGC
§876.5980	Tube, Levine	Class 2	FRQ
§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

FDA Technical Contact

Mark Antonino

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/

240-402-9980

Standards Development Organizations

AAMI	Association for the Advancement of Medical Instrumentation	http://www.aami.org
ANSI	American National Standards Institute	https://www.ansi.org/

FDA Specialty Task Group (STG)

ObGyn/Gastroenterology/Urology

*These are provided as examples and others may be applicable.