AccessGUDID - DEVICE: 16PW - Burn Relief (00766588030302)

GUDID

Device Identifier (DI) Information

Brand Name: 16PW - Burn Relief
Version or Model: K203-030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K203-030
Company Name: Certified Safety Manufacturing, Inc.

Primary DI Number: 00766588030302
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788460483 *Terms of Use

Device Description: 16PW - Burn Relief

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64420	Burn kit, medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it includes pharmaceuticals (e.g., topical analgesic, antibiotic). 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit with drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941311	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23ccb9fc-c423-475c-83b8-36c732f82510
Public Version Date: March 22, 2024
Public Version Number: 1
DI Record Publish Date: March 14, 2024