FDA UDI
In Commercial Distribution
🇺🇸 United States
Bleeding Control Basic Kit
DI: M689BCBK040
·
Model: 04
·
Safeguard US Operating, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bleeding Control Basic Kit
- Primary DI
- M689BCBK040
- Version / Model
- 04
- Catalog Number
- BCBK
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 4f4d2c92-1aea-49aa-9f0a-b56648a6b7e0
Device Description
First Responder kits are intended to be carried and used by dedicated non-medical First Responders. Vacuum-sealed pouch designed for treatment of Massive Hemorrhage- the leading cause of traumatic death. The kit includes Celox Rapid hemostatic gauze, a tourniquet of choice, exam gloves. It is designed to be carried in your cargo pocket for immediate response.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 | M689BCBK040 | HIBCC |