Duns Number:621904622
Device Description: Tactical Medical Kit - Massive Hemorrhage, Airway, Respirations, Circulation, Hypothermia Tactical Medical Kit - Massive Hemorrhage, Airway, Respirations, Circulation, Hypothermia Prevention, Multi-Cam, W/SOFTTW
Catalog Number
01437MC
Brand Name
TMK-MARCH Kit, Multi-Cam, W/SOFTTW
Version/Model Number
01437MC
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)
-
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
b09a7bfb-52b6-44a1-a130-23c63bedba9d
Public Version Date
August 09, 2019
Public Version Number
1
DI Record Publish Date
August 01, 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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |