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Watercraft First Aid Kit - 16 Poly White K626-014

by Certified Safety Manufacturing, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00766588260143 UDI-DI Date19 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1060-2022 FDA Class II initiated 5 Apr 2022

    First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Watercraft First Aid Kit - 16 Poly White
Generic Name
First aid kit, medicated
Model / Ref / Catalog
K626-014
Primary DI / UDI-DI
00766588260143
510(k) Number
FDA Product Code
LRR
GMDN Term
First aid kit, medicated
Device Class
N
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K940249)

Show all (12)

Other devices from Certified Safety Manufacturing, Inc.

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Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No