FDA UDI
In Commercial Distribution
🇺🇸 United States
VACSURE Disposable Tourniquets
DI: 00850014448332
·
Model: VS-DTD
·
LABOTEK GROUP CORP
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
Basic Information
- Brand Name
- VACSURE Disposable Tourniquets
- Primary DI
- 00850014448332
- Version / Model
- VS-DTD
- Company Name
- LABOTEK GROUP CORP
- Labeler DUNS
- 117338398
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 2
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- 2d745c33-3fb2-4977-96a0-48dd110724c4
Device Description
VACSURE Disposable Tourniquets, TPE Material, 1" x 18" Pre-Notched
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 67048 | Venous tourniquet, single-use | A device in the form of a narrow band or strap intended to be wrapped and manually tightened typically around a patient's arm to control/stop blood flow during collection of blood from a vein; it may additionally be used with a pressure bandage to apply pressure to a wound. 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; it is not fastened via a rotating handle mechanism (i.e., not a windlass). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850014448339 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00850014448332 | GS1 | ||||
| Package | 20850014448336 | GS1 | Case | 80 | In Commercial Distribution | |
| Unit of Use | 30850014448333 | GS1 |
Customer Contacts
- Phone
- 7877851555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit