Duns Number:039612668
Device Description: "(6) BURN GEL(1) FIRST AID FACTS GUIDE(1) FIRST AID TAPE(1) GAUZE BANDAGE COMPRESS(1) INST "(6) BURN GEL(1) FIRST AID FACTS GUIDE(1) FIRST AID TAPE(1) GAUZE BANDAGE COMPRESS(1) INSTANT ICE PACK(2) NITRILE GLOVES(4) NON-STICK PADS(16) 1 X 3" PLASTIC BANDAGES(6) 2 X 3" PLASTIC BANDAGES(1) RESCUE BLANKET(2) WATER-JEL BURN DRESSING - 4 X 4"(1) WATER-JEL BURN DRESSING - 4 X 16""
Catalog Number
H-4172
Brand Name
Uline Burn Kit - Single Use
Version/Model Number
H-4172
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
EFQ
Product Code Name
Gauze/Sponge, Internal
Public Device Record Key
d66d3f75-d700-45d5-8e10-b2819a7c7ecc
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
January 18, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 2 |