Duns Number:118492643
Device Description: This kit treats Massive Hemorrhage and comes in nylon holster style belt pouch. The kit co This kit treats Massive Hemorrhage and comes in nylon holster style belt pouch. The kit contains Celox Rapid hemostatic gauze, and tourniquet of choice and exam gloves. The pouch has a vertical belt loop and can be worn on your standard 2” wide utility and gun belts.
Catalog Number
88-115-03
Brand Name
Mojo Bleeder Holster Kit
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
b3be947c-867e-42b3-88c6-5437c20c17ff
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
March 16, 2018
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 |