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Medline OGBCS23GT

by Medline Industries, Inc.

Medline OGBCS23GT is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K151991 and listed in FDA GUDID since 7 May 2025 (UDI-DI 10197344112111), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151991↗

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 Number10197344112111 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK151991 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151991 Active
  • FDA GUDID UDI-DI 10197344112111 listed 7 May 2025 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Blood collection set, invasive
Model / Ref / Catalog
OGBCS23GT
Primary DI / UDI-DI
10197344112111
510(k) Number
FDA product code
FPA
GMDN term
Blood collection set, invasive
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)