AccessGUDID - DEVICE: Green Guard First Responder Kit (00347682011901)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard First Responder Kit
Version or Model: 1190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1190
Company Name: Greenguard

Primary DI Number: 00347682011901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: 3015 -1.000 EACH GG Alcohol Swabs (50) 6102 -1.000 EACH 2" RIP-N-WRAP 6520 -2.000 EACH Emergency Large Wound Dressing 3302 -4.000 EACH GG Cold Pack Medium/Boxed + 6400 -2.000 EACH GG Triangular Bandage + 8202 -1.000 EACH Paramedic Scissors 6253 -2.000 EACH Waterproof Tape 1/2" x 5yds 6254 -2.000 EACH Waterproof Tape 1"x5 yds 8522 -1.000 EACH Disposable Emergency Blanket + 4106 -2.000 EACH GG 8oz Eye Wash 6314 -1.000 EACH GG 1x3 Plastic Strip Bndg (60) 739MT -1.000 EACH TRAUMA KIT,STNDRD CORDURA BAG 7915 -1.000 EACH GG Sani-Safe Glove Dispenser 8070 - 1.000 EACH Emergency CPR Kit 6211 -1.000 EACH 4 X 4 Gauze Pads (10) 6205 -1.000 EACH GG 3x3 Gauze Pads (10) 6113 - 3.000 EACH 3" Stretch Roller Gauze 6248 -1.000 EACH Tape Tri-Cut Waterproof + 6213 -5.000 EACH 5x9 Combine Dressing ABD 8212I -1.000 EACH Penlight Disposable - Ind. 22312 -1.000 EACH Triple Antibiotic Ointment 10c 3161 -1.000 EACH WJ Burn Dressing 4x16 3160 -2.000 EACH WJ Burn Dressing 4x4 SS110 -1.000 EACH MCR Stratos Black/Clear 6615 -1.000 EACH Infectious Waste Bags (each) +

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:	No
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: 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: 85084b2d-3ad3-48cd-b2c4-e64aaa969841
Public Version Date: July 23, 2019
Public Version Number: 1
DI Record Publish Date: July 15, 2019