Device
Cement Burn Cabinet - 75H 2 Shelf Cabinet
Manufacturer
Certified Safety Manufacturing, Inc.
Model: K626-009 Catalog: K626-009 DI: 00766588260099 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
Cement Burn Cabinet - 75H 2 Shelf Cabinet
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: cdcd541e-acb0-4c06-8b82-327af3c99630
Distribution Status: In Commercial Distribution
DUNS Number: 788460483
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00766588260099
Type: Primary
Issuing Agency: GS1
GMDN
Code: 10516
Name: Burn kit, non-medicated
Definition:
A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.
FDA Product Codes
OJJ
Burn kit without drug
Premarket Submissions
Submission Number: K941311
Supplement Number: 000