Identity
- Trade Name
- AVANOS* FDA UDI
- Generic Name
- Cooling utility supply system FDA UDI
- Device Name
- CRA-QPU-1-L AVNS,LOANER PUMP UNT,PUMP,1 FDA UDI
- Model / Reference
- CRA-QPU-1-L FDA UDI
- Description
- CRA-QPU-1-L AVNS,LOANER PUMP UNT,PUMP,1 FDA UDI
Identifiers
- Catalog Number
- CRA-QPU-1-L FDA UDI
- Primary DI / UDI-DI
- 00193493000357 FDA UDI
- 510(k) Number
- K192491 FDA UDI
- FDA Product Code
- GXD FDA UDI
- GMDN Term
- Cooling utility supply system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4400 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
Avanos* 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.
- VIVA Pump — STARMED CO., LTD · Class II
- Cooling pump — RF Medical Co., Ltd. · Class II
- VIVA Pump — STARMED CO., LTD · Class II
- ThermoSuit System — Life Recovery Systems Hd, LLC · 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
- Halyard — Avanos Medical, Inc. · Class II
Cleared under the same submission
K192491 also covers:
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- COOLIEF* Basic Generator — Avanos Medical, Inc.
- COOLIEF* Basic-R Generator — Avanos Medical, Inc.
- COOLIEF* Cooled RF Advanced Generator — Avanos Medical, Inc.
- COOLIEF* Cooled RF Advanced-R Generator — Avanos Medical, Inc.
- COOLIEF* Multi-Cooled RF Therapy Cable — Avanos Medical, Inc.
- COOLIEF* Quad Pump Connector Cable — Avanos Medical, Inc.
- COOLIEF* Quad Pump Unit — Avanos Medical, Inc.
- COOLIEF* TRANDISCAL* Radiofrequency Therapy Cable — Avanos Medical, Inc.
- Multi-RF Therapy Cable — Avanos Medical, Inc.
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 161821d4-547f-49a6-99ff-95c554e13e1f 36 fields · synced Jun 9, 2026