Duns Number:118492643
Device Description: 1 Full Stop Tourniquet1 Compressed Gauze1 Thin H Bandage1 Wound Seal Kit1 Combat Medic Rei 1 Full Stop Tourniquet1 Compressed Gauze1 Thin H Bandage1 Wound Seal Kit1 Combat Medic Reinforcement Tape1 Pair Gloves
Catalog Number
ATRP0
Brand Name
Adult Trauma Response Pack
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 02, 9999
Issuing Agency
In HIBCC
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
8a1f53a0-152e-4e7b-b796-5aff621a4d38
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |