FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mojo Bleeder Holster Kit
DI: M689881150301
·
Model: 01
·
Safeguard US Operating, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mojo Bleeder Holster Kit
- Primary DI
- M689881150301
- Version / Model
- 01
- Catalog Number
- 88-115-03
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-16
- Public Version
- 4
- Public Version Date
- 2022-04-12
- Public Version Status
- Update
- Public Device Record Key
- 9c538485-5993-4ef4-bbe3-d7691fe76d55
- Distribution End Date
- 2020-10-31
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62004 | Wound dressing kit, medicated, non-sterile | A 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M689881150301 | HIBCC |