AccessGUDID - DEVICE: Medi-First Basic Plastic Burn Kit (00347682896102)

GUDID

Device Identifier (DI) Information

Brand Name: Medi-First Basic Plastic Burn Kit
Version or Model: 89610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 89610
Company Name: Medique Products

Primary DI Number: 00347682896102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086911794 *Terms of Use

Device Description: 1 -Antiseptic Wipes, 10ct 1 -1” x 3” Plastic Strips, 16ct 2 -4" x 4" Burn Dressings 2 -2" x 6" Burn Dressings 4 -Water Jel Burn Jel 3.5gm Pkts 2 -Vinyl Exam Gloves, Disp., Pair 2 -2” Stretch Roller Gauze 1 -1/2” x 5yds Adhesive Tape 1 -Scissors, 4.5” 1- Instruction Sheet

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?
10516	Burn kit, non-medicated	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJI	Burn Kit With Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bebaf9a5-51e0-40ba-a17a-e39bff7b3419
Public Version Date: September 10, 2019
Public Version Number: 2
DI Record Publish Date: July 19, 2019