Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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9-31
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Standard | |
ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors |
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Scope/AbstractThis standard specifies safety requirements for enteral feeding set connectors and adapters. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§876.5980 |
Tube, Nasogastric
|
Class 2
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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
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KNT
|
§876.5980 |
Intestinal Splinting Tubes
|
Class 2
|
LCG
|
§876.5980 |
Balloon, Liver Tamponade
|
Class 2
|
NGU
|
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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. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
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*These are provided as examples and others may be applicable. |
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