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Coolief*

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
COOLIEF* FDA UDI
Generic Name
Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Device Name
COOLIEF* Cooled Radiofrequency Introducer FDA UDI
Model / Reference
CRI-17-150-6 FDA UDI
Description
COOLIEF* Cooled Radiofrequency Introducer FDA UDI

Identifiers

Catalog Number
CRI-17-150-6 FDA UDI
Primary DI / UDI-DI
00193493442102 FDA UDI
510(k) Number
K053082 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

Coolief* by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator.

Cleared under the same submission

K053082 also covers:

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 3aa061c5-147c-42ee-b764-f6d4f4bdc6ca 36 fields · synced Jun 9, 2026