Identity
- Trade Name
- Sterile Disposable Contour Cuff FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- This cuff and protective sleeve is a sterile, single use product. This part number is a 34 inch model with dual port and single bladder. FDA UDI
- Model / Reference
- 60-7970-156-00 FDA UDI
- Description
- This cuff and protective sleeve is a sterile, single use product. This part number is a 34 inch model with dual port and single bladder. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995607970156001 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Tourniquet cuff, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tourniquet cuff, single-use
Sterile Disposable Contour Cuff by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, single-use.
- Disposable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Tourniquet Cuff — Vistar Medical Supplies Co.,Ltd. · Class I
- Tourniquet cuff — NINGBO ZHUOQIU MEDICAL EQUIPMENT CO., LTD. · Class I
- Pneumatic Tourniquet Cuff — Tiantai Typhung Medical Supplies Co., Ltd · Class I
- Cuissard garrot autoclavable conique adulte XL 12x90cm DDM — SPENGLER SAS · Class I
- TMT Rigid Holster Kit w/ Malice Clip Tactical Taylor Back Attachment — SAFEGUARD US OPERATING, LLC · Class I
- Mobile Stand for Tourniquet — VBM Medizintechnik GmbH · Class I
- Disposable cuff 2XL, standard connector, 10 pcs. — ATMOS MedizinTechnik GmbH & Co. KG · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc
Sources (1)
- FDA UDI 093594c7-5e93-4cbc-81d6-1dcc9a5e883b 34 fields · synced Jun 8, 2026