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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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 Tube, Nasogastric Class 2 BSS
§876.5980 Tray, Irrigation, Sterile Class 2 EYN
§876.5980 Catheter, Retention Type Class 2 EZK
§876.5980 Bag, Hemostatic Class 2 FCB
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Tube, Double Lumen For Intestinal Decompression And/Or Intubation Class 2 FEG
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Catheter, Retention, Barium Enema With Bag Class 2 FGD
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Levine Class 2 FRQ
§876.5980 Catheter, Rectal Class 2 GBT
§876.5980 Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Class 2 KDH
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
§876.5980 Intestinal Splinting Tubes Class 2 LCG
§876.5980 Balloon, Liver Tamponade Class 2 NGU
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Mark Antonino
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  240-402-9980
  Mark.Antonino@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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