Duns Number:621904622
Device Description: TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical supplies.
Catalog Number
01237REF
Brand Name
IFAK Insert Kit, Refill, Contents Only
Version/Model Number
01237REF
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
51f29e73-3de6-47db-83dc-2c5267e12f45
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 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 |