FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi-First Tourniquet
DI: 00347682660024
·
Model: 66002
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medi-First Tourniquet
- Primary DI
- 00347682660024
- Version / Model
- 66002
- Catalog Number
- 66002
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 3d5bddea-be28-436a-a93b-96e0fc772dad
Device Description
A device consisting of a strap intended to be wrapped around a patient's limb and tightened to reduce circulation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35844 | Limb tourniquet, manual, reusable | A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50347682660029 | GS1 | master case | 1000 | In Commercial Distribution | |
| Primary | 00347682660024 | GS1 |
Customer Contacts
- Phone
- 1-800-634-7680
- [email protected]