Duns Number:176528040
Device Description: 3015 -1.000 EACH GG Alcohol Swabs (50)6102 -1.000 EACH 2" RIP-N-WRAP6520 -2.000 EACH Emerg 3015 -1.000 EACH GG Alcohol Swabs (50)6102 -1.000 EACH 2" RIP-N-WRAP6520 -2.000 EACH Emergency Large Wound Dressing3302 -4.000 EACH GG Cold Pack Medium/Boxed +6400 -2.000 EACH GG Triangular Bandage +8202 -1.000 EACH Paramedic Scissors6253 -2.000 EACH Waterproof Tape 1/2" x 5yds6254 -2.000 EACH Waterproof Tape 1"x5 yds8522 -1.000 EACH Disposable Emergency Blanket +4106 -2.000 EACH GG 8oz Eye Wash6314 -1.000 EACH GG 1x3 Plastic Strip Bndg (60)739MT -1.000 EACH TRAUMA KIT,STNDRD CORDURA BAG7915 -1.000 EACH GG Sani-Safe Glove Dispenser8070 - 1.000 EACH Emergency CPR Kit6211 -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 Gauze6248 -1.000 EACH Tape Tri-Cut Waterproof +6213 -5.000 EACH 5x9 Combine Dressing ABD8212I -1.000 EACH Penlight Disposable - Ind.22312 -1.000 EACH Triple Antibiotic Ointment 10c3161 -1.000 EACH WJ Burn Dressing 4x163160 -2.000 EACH WJ Burn Dressing 4x4SS110 -1.000 EACH MCR Stratos Black/Clear6615 -1.000 EACH Infectious Waste Bags (each) +
Catalog Number
1190
Brand Name
Green Guard First Responder Kit
Version/Model Number
1190
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit With Drug
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
Package DI Number
50347682011906
Quantity per Package
1
Contains DI Package
00347682011901
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |