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Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 9-31: AAMI / ANSI ID54:1996/(R)2012, enteral feeding set adapters and connectors. (ObGyn/Gastroenterology/Urology)

Date of Standard: 1996. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
CDRH Office and Division associated with recognized standards:
Devices Affected:
Enteral feeding tubes and accessories - gravity and pump-assisted devices
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§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, W Mercury Wt Balloon For Intes. Intub. &/Or Decompression Class 2 FEF
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contacts:
 Joshua Silverstein
  10903 New Hampshire Avenue WO66 RM1615
  Silver Spring MD 20903
  email: joshua.silverstein@fda.hhs.gov
 Jeffrey Cooper
  10903 New Hampshire Avenue WO66 RMG228
  Silver Spring MD 20993
  email: jeffrey.cooper@fda.hhs.gov