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Hcs 5000OB

by Concordance Healthcare Solutions LLC

Hcs 5000OB is a Class I device made by Concordance Healthcare Solutions LLC, listed in FDA GUDID since 5 Dec 2025 (UDI-DI 00810132043413), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810132043413 UDI-DI Date5 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hcs
Generic name
Venous tourniquet, single-use
Model / reference
5000OB
Primary DI / UDI-DI
00810132043413
FDA product code
GAX
GMDN term
Venous tourniquet, single-use
Device class
Class I
Regulation number
878.5900
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GAX (Tourniquet, Nonpneumatic).

Other devices from Concordance Healthcare Solutions LLC

See all devices from Concordance Healthcare Solutions LLC →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)