Duns Number:176528040
Device Description: 1143 -1.000 EACH GG 16 Unit Kit Metal Empty6252 -1.000 EACH Tape 1/2" X 2 1/2 Y62612 -1.00 1143 -1.000 EACH GG 16 Unit Kit Metal Empty6252 -1.000 EACH Tape 1/2" X 2 1/2 Y62612 -1.000 EACH Fingertip Woven M/L 10s62730 -1.000 EACH Woven Knuckle 8s3040B -2.000 EACH Ammonia Inhalant Wipes BULK3041B- 3.000 EACH Insect Sting relief Pads BULK3302 -1.000 EACH GG Cold Pack Medium/Boxed +6213 -2.000 EACH 5x9 Combine Dressing ABD8205 -1.000 EACH Kit Scissors8203 -1.000 EACH Plastic Single-use Tweezer9016B -1.000 EACH First Aid Booklets Ind. for +6397B -5.000 EACH Butterfly Bandage22312 -1.000 EACH Triple Antibiotic Ointment 10c6112 -1.000 EACH 2" Stretch Roller Gauze NS221B -0.002 M ALCOHOL PREP PADS612B -0.002 M GAUZE 3X3 21412 - 1.000 EACH Antiseptic Towelette 5X7 10s80201 -1.000 EACH CPR Mask3160 -1.000 EACH WJ Burn Dressing 4x420669 -1.000 EACH Burn Cream w/Lidocaine Unit (14154B -2.000 EACH Large Eye Pads 4110 -1.000 EACH GG 1oz Eye Wash17378 -0.006 M Hand Sanitizer 60075 -1.000 EACH 1"X3" Plastic Strip 16s6400 -1.000 EACH GG Triangular Bandage +ANSI-A -1.000 EACH ANSI STICKER A
Catalog Number
1142
Brand Name
Green Guard Medium Vehicle Kit
Version/Model Number
1142
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
f0dd59ba-4cab-42b7-a6f4-2b87929920fc
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50347682114225
Quantity per Package
16
Contains DI Package
00347682114220
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 |