Identity
- Trade Name
- Vari-Fit Reusable FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Delfi reusable tourniquet cuffs are available in various models for extra small adult to large adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. (Dual Port, Single Bladder, Contour Lower Leg Cuff) FDA UDI
- Model / Reference
- 60-7450-004-00 FDA UDI
- Description
- Delfi reusable tourniquet cuffs are available in various models for extra small adult to large adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. (Dual Port, Single Bladder, Contour Lower Leg Cuff) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995607450004001 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Tourniquet cuff, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tourniquet cuff, reusable
Vari-Fit Reusable by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tourniquet cuff, reusable.
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- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Reusable Conical Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc
Sources (1)
- FDA UDI f26c18da-98b2-45e0-b05b-8157df9c7626 34 fields · synced May 30, 2026