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GVS SQ40s

by Gvs Tm, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810197810170 UDI-DI Date19 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1157-2026 FDA Class II initiated 3 Nov 2025

    Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gvs
Generic Name
Blood transfusion filter
Model / Reference
SQ40s
Primary DI / UDI-DI
10810197810170
510(k) Number
FDA Product Code
CAK
GMDN Term
Blood transfusion filter
Device Class
Class II
Regulation Number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K960993)

Other devices from Gvs Tm, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No