Identity
- Trade Name
- COOLIEF* Cooled RF Introducer 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
- 44207 FDA UDI
- Description
- Coolief* Cooled Radiofrequency Introducer FDA UDI
Identifiers
- Catalog Number
- CRI-17-75-5.5 FDA UDI
- Primary DI / UDI-DI
- 10680651442076 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
COOLIEF* Cooled RF Introducer 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.
- COOLIEF* Cooled RF Introducer — Avanos Medical, Inc. · Class II
- COOLIEF* — Avanos Medical, Inc. · 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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 3d785c98-3f46-4322-ac9f-7755ff463f22 35 fields · synced Jun 9, 2026