Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Device Name
- CRA-TBK-1 AVNS,TUBING KIT, ONE PROBE,1 FDA UDI
- Model / Reference
- CRA-TBK-1 FDA UDI
- Description
- CRA-TBK-1 AVNS,TUBING KIT, ONE PROBE,1 FDA UDI
Identifiers
- Catalog Number
- CRA-TBK-1 FDA UDI
- Primary DI / UDI-DI
- 00193493000197 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Cardiac ablation system irrigation tubing set 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
Yes
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: Cardiac ablation system irrigation tubing set
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 4626d646-9bfa-4a07-96aa-2922f7c7e407 35 fields · synced Jun 9, 2026