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VIVA Pump

FDA UDI

Class II (US FDA UDI)

by Starmed Co., Ltd

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 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

Catalog Number
VP01 FDA UDI
Primary DI / UDI-DI
08809306769015 FDA UDI
510(k) Number
K163450 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
Not 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

No

FDA UDI

Dimensions & Sizes

Size
Weight — 4 Kilogram FDA UDI
Depth — 135 Millimeter FDA UDI
Height — 160 Millimeter FDA UDI
Width — 193 Millimeter FDA UDI

VIVA Pump by Starmed Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163450 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Starmed Co., Ltd

Sources (1)

  • FDA UDI 10e7dd4d-e5f1-414f-8254-5061015e0e21 38 fields · synced Jun 8, 2026