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McKesson 16-SFS0512

by Mckesson Medical-Surgical Inc.

McKesson 16-SFS0512 is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K150143 on 31 Aug 2015 and listed in FDA GUDID since 3 Oct 2025 (UDI-DI 20612479279258), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K150143

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 Number20612479279258 UDI-DI Date3 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150143 Date31 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150143 decided 31 Aug 2015 Active
  • FDA GUDID UDI-DI 20612479279258 listed 3 Oct 2025 Listed

Recalls

1 recall · FDA

    • Terminated Z-0926-2017 FDA Class I initiated 4 Oct 2016

    Potential contamination with B. cepacia.

Timeline

3 dated events

  1. Cleared FDA 510(k) K150143
  2. Recall initiated FDA recalls Z-0926-2017
  3. Listed FDA GUDID 20612479279258

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
McKesson
Generic name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Model / reference
16-SFS0512
Primary DI / UDI-DI
20612479279258
510(k) Number
FDA product code
NGT
GMDN term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K150143)

and 8 more cleared under K150143

Similar devices

Other devices filed under FDA product code NGT (Saline, Vascular Access Flush).

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

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