Identity
- Trade Name
- VIVA Pump FDA UDI
- Generic Name
- Cooling utility supply system FDA UDI
- Device Name
- The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF Electrode. The chilled water is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is enclosed system within the electrode and the water is not to be in contact with the patient. FDA UDI
- Model / Reference
- VP01-1 FDA UDI
- Description
- The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF Electrode. The chilled water is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is enclosed system within the electrode and the water is not to be in contact with the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306769107 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Cooling utility supply system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4 Kilogram FDA UDIDepth — 135 Millimeter FDA UDIHeight — 160 Millimeter FDA UDIWidth — 193 Millimeter FDA UDI
Category: Cooling utility supply system
VIVA Pump by Starmed Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cooling utility supply system.
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- COOLIEF* Quad Pump Unit — Avanos Medical, Inc. · Class II
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- COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit — Avanos Medical, Inc. · Class II
- ThermoSuit System — Life Recovery Systems Hd, LLC · Class II
- Halyard — Avanos Medical, Inc. · Class II
- VIVA Pump — STARMED CO., LTD · Class II
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
- Starmed Co., Ltd
Sources (1)
- FDA UDI 798073bc-e57b-49ad-8c7e-94370dda7b58 35 fields · synced May 30, 2026