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Burn Dressing Large - Red Velcro Bag K626-006

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 Number00766588260068 UDI-DI Date6 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1353-2018 FDA Class II initiated 20 Mar 2018 on shared 510(k) K941311

    Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Burn Dressing Large - Red Velcro Bag
Generic Name
Burn kit, non-medicated
Model / Ref / Catalog
K626-006
Primary DI / UDI-DI
00766588260068
510(k) Number
FDA Product Code
OJJ
GMDN Term
Burn kit, non-medicated
Device Class
Class I
Regulation Number
878.4022
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K941311)

Other devices from Certified Safety Manufacturing, Inc.

See all devices from Certified Safety Manufacturing, Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • 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