Med-Rx 54-1650R
by Canadian Hospital Specialties Limited
Med-Rx 54-1650R is a Class II device made by Canadian Hospital Specialties Limited, cleared under FDA 510(k) K100700 on 13 Dec 2010 and listed in FDA GUDID since 20 Oct 2016 (UDI-DI 00628725002958), active as of 23 Oct 2026. 6 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00628725002958 | Date20 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100700 | Date13 Dec 2010 | StatusActive |
Official records
- AccessGUDID record 00628725002958
- FDA 510(k) database K100700
Across registries
- FDA 510(k) K100700 decided 13 Dec 2010 Active
- FDA GUDID UDI-DI 00628725002958 listed 20 Oct 2016 Listed
Recalls
-
- Terminated Z-2293-2019
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
-
- Terminated Z-2281-2019
The firm received a complaint that the connector detached from the feeding tube.
-
- Terminated Z-0746-2019
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
-
- Terminated Z-0725-2019
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
-
- Terminated Z-2440-2018
The product may be packaged with the incorrect length of feeding tube as labeled.
-
- Terminated Z-0595-2016
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Timeline
- Cleared FDA 510(k) K100700
- Recall initiated FDA recalls Z-0595-2016
- Listed FDA GUDID 00628725002958
- Recall initiated FDA recalls Z-2440-2018
- Recall initiated FDA recalls Z-0725-2019
- Recall initiated FDA recalls Z-0746-2019
- Recall initiated FDA recalls Z-2281-2019
- Recall initiated FDA recalls Z-2293-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Med-Rx
- Generic name
- Nasogastric feeding tube
- Model / Ref / Catalog
- 54-1650R
- Primary DI / UDI-DI
- 00628725002958
- 510(k) Number
- FDA product code
- FPD
- GMDN term
- Nasogastric feeding tube
- Device class
- Class II
- Regulation number
- 876.5980
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FPD (Tube, Feeding).
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- EXTERNAL FEEDING SET FOR PUMP USE by Multi-Med, Inc.
- NEOMED Enteral FEEDING TUBE by NEOMED, INC.
- Nutrifit by Vygon USA
- VYGON 6155.272 006155272 by VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG
- L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE by Intl. Medical Marketing, Inc.
- MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES by Benlan, Inc.
- NUTRISAFE PUR ENTERAL FEEDING TUBE by Vygon Corp.
- NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE by Sandoz Nutrition
- JEJUNO-CATH KIT by Health Improvement Assoc.
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