Cooling pump

FDA UDI

Class II (US FDA UDI)

by RF Medical Co., Ltd.

Identity

Trade Name: Cooling pump FDA UDI
Generic Name: Cooling utility supply system FDA UDI
Device Name: The Cooling pump RFP-300 is used to cooling of the electrodes by circulating saline solution. FDA UDI
Model / Reference: RFP-300 FDA UDI
Description: The Cooling pump RFP-300 is used to cooling of the electrodes by circulating saline solution. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809295147054 FDA UDI
510(k) Number: K180999 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 210 Millimeter FDA UDI
Depth — 274 Millimeter FDA UDI
Width — 200 Millimeter FDA UDI
Weight — 3.75 Kilogram FDA UDI

Category: Cooling utility supply system

Cooling pump by RF Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cooling utility supply system.

VIVA Pump — STARMED CO., LTD · Class II
AVANOS* — Avanos Medical, Inc. · Class II
AVANOS* — Avanos Medical, Inc. · Class II
COOLIEF* Quad Pump Unit — Avanos Medical, Inc. · Class II
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit — Avanos Medical, Inc. · Class II
VIVA Pump — STARMED CO., LTD · Class II
ThermoSuit System — Life Recovery Systems Hd, LLC · Class II
Halyard — Avanos Medical, Inc. · Class II

Cleared under the same submission

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: RF Medical Co., Ltd.

Sources (1)

FDA UDI 477e2b59-dc11-486d-a86c-ee4e9663d3f9 37 fields · synced May 30, 2026