Identity
- Trade Name
- Sterile Single-use Tourniquet Cuff EUDAMEDN/A FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Sterile Single-use Tourniquet Cuff EUDAMEDSTERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 30 IN FDA UDI
- Model / Reference
- VTS-126 EUDAMEDVT-126 FDA UDI
- Description
- STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 30 IN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521872326 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187DSTQSRG EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
Sterile Single-use Tourniquet Cuff by Vistar Medical Supplies Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697352187DSTQSRG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vistar Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000011207
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 7d9dccd5-1bba-4a2c-b776-d0dc92a222ec 61 fields · synced Jul 27, 2026
- FDA UDI f79b92b0-8939-4340-97cc-45b199264d1c 34 fields · synced May 24, 2026