Recognition List Number: 016 Publication Date: 11/03/2006
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-31: AAMI / ANSI ID54:1996/(R)2005, Enteral feeding set adapters and connectors. (ObGyn/Gastroenterology)
Date of Standard: 1996. |
| Addresses of Standards 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 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| 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: |
| Vertical, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
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, W Mercury Wt Balloon For Intes. Intub. &/Or Decompression |
Class 2 |
FEF |
| §876.5980 |
Tubes, Gastrointestinal (And Accessories) |
Class 2 |
KNT |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Carolyn Neuland |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G226 |
| Silver Spring MD 20993 |
| 301/796-6523 |
| Email: carolyn.neuland@fda.hhs.gov |
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