FDA.reportPublic FDA data

Mojo Bleeder Holster Kit

Primary DI
M689881150301
Brand
Mojo Bleeder Holster Kit
Company
Safeguard US Operating, LLC
Model
01
Catalog number
88-115-03
Device description
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.
Published
2018-02-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M689881150301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicated, non-sterileA collection of non-sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Combination product
true

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