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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Mark Antonino
  FDA/OMPT/CDRH/ODE/DRGUD/GEDB/
  240-402-9980
  Mark.Antonino@fda.hhs.gov
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
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