FDA UDI
In Commercial Distribution
🇺🇸 United States
Mojo TMT Holster Kit
DI: M6898811501020
·
Model: 02
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mojo TMT Holster Kit
- Primary DI
- M6898811501020
- Version / Model
- 02
- Catalog Number
- 88-115-01
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-03
- Public Version
- 1
- Public Version Date
- 2022-10-11
- Public Version Status
- New
- Public Device Record Key
- 97e01878-9516-4f3b-a433-04d8f5c61169
Device Description
This kit treats Massive Hemorrhage and comes in nylon holster style belt pouch. The kit contains a tourniquet of choice. 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)
- Yes
- Kit
- Yes
- Combination Product
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35925 | Tourniquet cuff, single-use | A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M6898811501020 | HIBCC |