AccessGUDID - DEVICE: Green Guard Small Burn Kit (00347682011970)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard Small Burn Kit
Version or Model: 1197
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1197
Company Name: Greenguard

Primary DI Number: 00347682011970
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: 1139 -1.000 EACH 10 Unit Kit Empty Plastic 3160 -2.000 EACH WJ Burn Dressing 4x4 7920 -1.000 EACH Glove Wipes 20669 -1.000 EACH Burn Cream w/Lidocaine Unit (1 3002 -1.000 EACH GG Derma Cool (2 oz.) 6117 -1.000 EACH 3" Sterile Gauze Roll 9010B -1.000 EACH Burn Relief Kit Stickers 6253 -1.000 EACH Waterproof Tape 1/2" x 5yds 6205 -1.000 EACH GG 3x3 Gauze Pads (10)

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: eacbe860-6b59-43f5-bf66-2709584dea9d
Public Version Date: September 10, 2019
Public Version Number: 2
DI Record Publish Date: July 15, 2019