AccessGUDID - DEVICE: Uline Burn Kit - Single Use (10851253007691)

GUDID

Device Identifier (DI) Information

Brand Name: Uline Burn Kit - Single Use
Version or Model: H-4172
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H-4172
Company Name: ULINE, INC.

Primary DI Number: 10851253007691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039612668 *Terms of Use

Device Description: BURN GEL, FIRST AID FACTS GUIDE, FIRST AID TAPE, GAUZE BANDAGE COMPRESS, INSTANT ICE PACK, NITRILE GLOVES, NON-STICK PADS, 1 X 3" PLASTIC BANDAGES, 2 X 3" PLASTIC BANDAGES, RESCUE BLANKET, BURN DRESSING - 4 X 4", BURN DRESSING - 4 X 16"

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):	Yes
Kit:	Yes
Combination Product:	Yes
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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable 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 [?]
Premarket Submission Number Not Available/Not Released

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: d66d3f75-d700-45d5-8e10-b2819a7c7ecc
Public Version Date: June 04, 2024
Public Version Number: 9
DI Record Publish Date: January 18, 2019