Duns Number:118492643
Device Description: Mojo Medical Bags are equipped withMARCH Medical Gear in our simplified,color-coded treatm Mojo Medical Bags are equipped withMARCH Medical Gear in our simplified,color-coded treatment system linkingicon identifiers to a treatment categorywithin the MARCH protocol.MASSIVE HEMORRHAGEAIRWAYRESPIRATIONCIRCULATIONHEAD & HYPOTHERMIA
Catalog Number
84-497
Brand Name
Mojo Direct Action - Advanced
Version/Model Number
05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 31, 2023
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
002e03d3-163c-42c1-b9ff-8bf69411fe01
Public Version Date
April 12, 2022
Public Version Number
3
DI Record Publish Date
October 29, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |