Duns Number:176528040
Device Description: 1136 -1.000 EACH GG 10 Unit Kit Metal Empty3302 -1.000 EACH GG Cold Pack Medium/Boxed +206 1136 -1.000 EACH GG 10 Unit Kit Metal Empty3302 -1.000 EACH GG Cold Pack Medium/Boxed +20669 -1.000 EACH Burn Cream w/Lidocaine Unit (160075- 1.000 EACH 1"X3" Plastic Strip 16s62612 -1.000 EACH Fingertip Woven M/L 10s6252 -1.000 EACH Tape 1/2" X 2 1/2 Y6112 -=1.000 EACH 2" Stretch Roller Gauze NS6201 -1.000 EACH GG 2x2 Gauze Pads (10)8203 -1.000 EACH Plastic Single-use Tweezer9016B -1.000 EACH First Aid Booklets Ind. for +3101B -2.000 EACH GG Triple Antibiotic .5gr3025B -2.000 EACH Antiseptic Towlettes3103B -2.000 EACH GG Hydrocortisone .9gr645B -0.002 M HW Latex Free Woven Knuckle3041B -3.000 EACH Insect Sting relief Pads 8205 -1.000 EACH Kit Scissors7920 -1.000 EACH Glove Wipes
Catalog Number
1135
Brand Name
Green Guard Small Vehicle Kit
Version/Model Number
1135
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
-
Product Code Name
-
Public Device Record Key
e564ca4b-419a-4879-a1cb-05e1f29a3425
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |