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Med-Rx 54-1042R

by Canadian Hospital Specialties Limited

Med-Rx 54-1042R 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 29 Mar 2021 (UDI-DI 00628725003917), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

510(k) K100700

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628725003917 UDI-DI Date29 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100700 Date13 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100700 decided 13 Dec 2010 Active
  • FDA GUDID UDI-DI 00628725003917 listed 29 Mar 2021 Listed

Recalls

6 recalls · FDA

    • Terminated Z-2293-2019 FDA Class II initiated 22 Jul 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 FDA Class II initiated 16 Jul 2019

    The firm received a complaint that the connector detached from the feeding tube.

    • Terminated Z-0746-2019 FDA Class II initiated 17 Dec 2018

    Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.

    • Terminated Z-0725-2019 FDA Class II initiated 1 Dec 2018

    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 FDA Class II initiated 11 Jun 2018

    The product may be packaged with the incorrect length of feeding tube as labeled.

    • Terminated Z-0595-2016 FDA Class II initiated 11 Dec 2015

    The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

Timeline

8 dated events

  1. Cleared FDA 510(k) K100700
  2. Recall initiated FDA recalls Z-0595-2016
  3. Recall initiated FDA recalls Z-2440-2018
  4. Recall initiated FDA recalls Z-0725-2019
  5. Recall initiated FDA recalls Z-0746-2019
  6. Recall initiated FDA recalls Z-2281-2019
  7. Recall initiated FDA recalls Z-2293-2019
  8. Listed FDA GUDID 00628725003917

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Med-Rx
Generic name
Nasogastric feeding tube
Model / Ref / Catalog
54-1042R
Primary DI / UDI-DI
00628725003917
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

Related devices

Category: Nasogastric feeding tube

Cleared under the same submission (K100700)

and 8 more cleared under K100700

Similar devices in this category

Other devices filed under Nasogastric feeding tube.

Other devices from Canadian Hospital Specialties Limited

See all devices from Canadian Hospital Specialties Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)