Duns Number:621904622
Device Description: TMK-IFAK Pouch and Insert Kit includes the necessary medical supplies to treat the three l TMK-IFAK Pouch and Insert Kit includes the necessary medical supplies to treat the three leading causes of preventable deaths on the battlefield.
Catalog Number
01239BK-CAT
Brand Name
IFAK Pouch & Insert Kit, Black w/CAT
Version/Model Number
01239BK-CAT
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
668afda6-5d2e-4cfc-ae00-87772705bc68
Public Version Date
June 03, 2020
Public Version Number
1
DI Record Publish Date
May 26, 2020
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |