AccessGUDID - DEVICE: Green Guard Deluxe Vehicle Kit (00347682110666)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard Deluxe Vehicle Kit
Version or Model: 1105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1105
Company Name: Greenguard

Primary DI Number: 00347682110666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: 1106 -1.000 EACH GG Deluxe Truck Kit Emp 36u 6300 -1.000 EACH GG 7/8x3 Fabric Strip Bandage (50) 8205 -1.000 EACH Kit Scissors 8203 -1.000 EACH Plastic Single-use Tweezer 6112 -1.000 EACH 2" Stretch Roller Gauze NS 22312 -1.000 EACH Triple Antibiotic Ointment 10c 6102 -1.000 EACH 2" RIP-N-WRAP 62612 -1.000 EACH Fingertip Woven M/L 10s 62730 -1.000 EACH Woven Knuckle 8s 6213 -2.000 EACH 5x9 Combine Dressing ABD 60075 -1.000 EACH 1"X3" Plastic Strip 16s 6400 -1.000 EACH GG Triangular Bandage + 6252 -1.000 EACH Tape 1/2" X 2 1/2 Y 3302 -2.000 EACH GG Cold Pack Medium/Boxed + 9016B -1.000 EACH First Aid Booklets Ind. for + 3004 -1.000 EACH GG Hydrogen Peroxide 2oz pump 612B -0.005 M GAUZE 3X3 - 7920 -2.000 EACH Glove Wipes 21412 -1.000 EACH Antiseptic Towelettes 5X7 10s 80201 -1.000 EACH CPR Mask 3160 1-.000 EACH WJ Burn Dressing 4x4 20669 -1.000 EACH Burn Cream w/Lidocaine Unit 4154B -2.000 EACH Large Eye Pads BULK 4110 -1.000 EACH GG 1oz Eye Wash 17378- 0.006 M Hand Sanitizer Bulk ANSI-A -1.000 EACH ANSI STICKER A

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: e909b960-8867-49c7-ac79-1aed44f26cd5
Public Version Date: July 23, 2019
Public Version Number: 1
DI Record Publish Date: July 15, 2019