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COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit FDA UDI
Generic Name
Cooling utility supply system FDA UDI
Device Name
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit FDA UDI
Model / Reference
TDA-PPU-1 FDA UDI
Description
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit FDA UDI

Identifiers

Catalog Number
TDA-PPU-1 FDA UDI
Primary DI / UDI-DI
00193493993062 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

No

FDA UDI

Category: Cooling utility supply system

COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cooling utility supply system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI b46ee745-25c2-4108-b722-f39069946e90 35 fields · synced Jun 9, 2026