Identity
- Trade Name
- Vari-Fit Reusable FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. This part number is specifically used for Arm. Reusable tourniquet cuffs must be inspected before use. This product is subject to wear and deteriorates with use. FDA UDI
- Model / Reference
- 9-7350-002 FDA UDI
- Description
- Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. This part number is specifically used for Arm. Reusable tourniquet cuffs must be inspected before use. This product is subject to wear and deteriorates with use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995973500021 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
Similar devices
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 eb0dc1ec-7095-4b1e-998b-fc00fe9110be 34 fields · synced Jun 8, 2026