AccessGUDID - DEVICE: Green Guard Super Utility Kit (00347682011253)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard Super Utility Kit
Version or Model: 1125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1125
Company Name: Greenguard

Primary DI Number: 00347682011253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: 1126 -1.000 EACH GG 2 Shelf Cabinet Emp w/Pkt 62730 -1.000 EACH Woven Knuckle 8s 6507 -1.000 EACH GG Hydrocortisone Unit (10) 62612 -1.000 EACH Fingertip Woven M/L 10s 6314 -1.000 EACH GG 1x3 Plastic Strip Bndg (60) 6253 -1.000 EACH Waterproof Tape 1/2" x 5yds 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 4105 -1.000 EACH GG 4oz Eye Wash 2209 - 1.000 EACH Pain & Ache relief (100) 6400 -2.000 EACH GG Triangular Bandage + 6213 -4.000 EACH 5x9 Combine Dressing ABD 3004 -1.000 EACH GG Hydrogen Peroxide 2oz pump 3002 -1.000 EACH GG Derma Cool (2 oz.) 1125PI- 1.000 EACH Pocket Items 2 shelf Kit 3302 -2.000 EACH GG Cold Pack Medium/Boxed + 66002 -1.000 EACH Latex Free Tourniquet 76001 -1.000 EACH Multi-Purpose Splint Folded 6112 -2.000 EACH 2" Stretch Roller Gauze NS 6114 -1.000 EACH 4" Stretch Roller Gauze 3106 -1.000 EACH GG Derma-Caine Burn Cream (25) 3101 -1.000 EACH GG Tri-Antibiotic Ointment (25) 3025 -2.000 U GG Antiseptic Towelettes (25) 80201 -1.000 EACH CPR Mask 3160 -2.000 EACH WJ Burn Dressing 4x4 6252- 1.000 EACH Tape 1/2" X 2 1/2 Y ANSI-B -1.000 EACH ANSI STICKER B

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: 7b5df33a-bed2-4a8b-aad3-5a659925064c
Public Version Date: July 23, 2019
Public Version Number: 1
DI Record Publish Date: July 15, 2019