Duns Number:118492643
Device Description: Equips trained medical first responders with a higher density of the core components ident Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol.• The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Catalog Number
84-493
Brand Name
Mojo Direct Action Bag - Intermediate
Version/Model Number
01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
12a04920-f198-44d2-a04c-0f7443e7b029
Public Version Date
April 12, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2017
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 |