Identity
- Trade Name
- Venclose System Power Cord FDA UDI
- Generic Name
- Electrical mains power cable FDA UDI
- Device Name
- Power Cord, Israel FDA UDI
- Model / Reference
- VCPCH FDA UDI
- Description
- Power Cord, Israel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858254006138 FDA UDI
- 510(k) Number
- K160754 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrical mains power cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical mains power cable
Venclose System Power Cord by Venclose Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160754 also covers:
- Venclose System Foot Pedal — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose™ EVSRF™ Catheter — VENCLOSE INC
- Venclose™ EVSRF™ Catheter — VENCLOSE INC
- Venclose™ EVSRF™ Catheter — VENCLOSE INC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Venclose Inc
Sources (1)
- FDA UDI 71e10b16-a87f-4c43-879b-cd3851c13947 34 fields · synced May 30, 2026