Duns Number:176528040
Device Description: 1106NSB -1.000 EACH Deluxe Truck Kit Empty NS +6254 -1.000 EACH Waterproof Tape 1"x5 yds61 1106NSB -1.000 EACH Deluxe Truck Kit Empty NS +6254 -1.000 EACH Waterproof Tape 1"x5 yds6117 -3.000 EACH 3" Sterile Gauze Roll7920 --2.000 EACH Glove Wipes 3160 -3.000 EACH WJ Burn Dressing 4x43161 -1.000 EACH WJ Burn Dressing 4x163002 -2.000 EACH GG Derma Cool (2 oz.)20669-1.000 EACH Burn Cream w/Lidocaine Unit (18200 -1.000 EACH 5 1/2" Band Scissors4106 -1.000 EACH GG 8oz Eye Wash6205 -1.000 EACH GG 3x3 Gauze Pads (10)9010B -1.000 EACH Burn Relief Kit Stickers
Catalog Number
1198
Brand Name
Green Guard Deluxe Burn Kit
Version/Model Number
1198
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
Yes
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
OJI
Product Code Name
Burn Kit With Drug
Public Device Record Key
157aa1b0-6ce2-4a93-bc07-5594eb38cb27
Public Version Date
February 03, 2020
Public Version Number
3
DI Record Publish Date
July 15, 2019
Package DI Number
50347682011982
Quantity per Package
1
Contains DI Package
00347682011987
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 |