AccessGUDID - DEVICE: Green Guard Deluxe Trauma Kit (00347682011963)

GUDID

Device Identifier (DI) Information

Brand Name: Green Guard Deluxe Trauma Kit
Version or Model: 1196
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1196
Company Name: Greenguard

Primary DI Number: 00347682011963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176528040 *Terms of Use

Device Description: 6115 -3.000 EACH 2" Sterile Gauze Roll 6117 -3.000 EACH 3" Sterile Gauze Roll 6400 -3.000 EACH GG Triangular Bandage + 6213 -4.000 EACH 5x9 Combine Dressing ABD 3302 -4.000 EACH GG Cold Pack Medium/Boxed + 6254 -2.000 EACH Waterproof Tape 1"x5 yds 6253 -2.000 EACH Waterproof Tape 1/2" x 5yds 8060 -1.000 EACH CPR Microshield 3015 -2.000 EACH GG Alcohol Swabs (50) 8053 -1.000 EACH Disposable Airway Assorted Siz 6397 -1.000 EACH GG Butterfly Bndg (10) 6603 -1.000 EACH Cotton Tip Appl 3" 100/Vial+ 4105 -1.000 EACH GG 4oz Eye Wash 4106 -1.000 EACH GG 8oz Eye Wash 6102 -1.000 EACH 2" RIP-N-WRAP 6103 -1.000 EACH 3" RIP-N-WRAP 3101 -1.000 EACH GG Tri-Antibiotic Ointment (25) 6300 -1.000 EACH GG 7/8x3 Fabric Strip Bandage (50) 6314 -1.000 EACH GG 1x3 Plastic Strip Bandage (60) 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 6202 -1.000 EACH GG 2x2 Gauze Pads (25) 8215 -1.000 EACH Labtron Stethoscope 8213 -1.000 EACH Blood Pressure Unit Adult w/ca 7920 -2.000 EACH Glove Wipes 8202 -1.000 EACH Paramedic Scissors 8200 -1.000 EACH 5 1/2" Band Scissors 1193 -1.000 EACH Trauma Kit Hard Pack (Empty) 8524 -2.000 EACH Space Blanket +

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: 7844f9fb-0d2a-4d4a-8466-f832e6dcc2ee
Public Version Date: July 23, 2019
Public Version Number: 1
DI Record Publish Date: July 15, 2019