FDA UDI
In Commercial Distribution
🇺🇸 United States
NAR
DI: 00842209118588
·
Model: 30-0291
·
NORTH AMERICAN RESCUE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NAR
- Primary DI
- 00842209118588
- Version / Model
- 30-0291
- Company Name
- NORTH AMERICAN RESCUE, LLC
- Labeler DUNS
- 832426782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 2
- Public Version Date
- 2024-02-13
- Public Version Status
- Update
- Public Device Record Key
- 8bbd87ba-92e7-4001-bd16-02e84bc12248
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67046 | Emergency tourniquet, manual, single-use | A device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening bleeding (e.g., in a military setting and/or high-risk work environment); it may additionally be used in non-life-threatening injuries. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842209118588 | GS1 |