Identity
- Trade Name
- RTX CIRCULATING CASSETTE WITHOUT ELECTROLYTE FDA UDI
- Generic Name
- Intravascular core temperature regulation system FDA UDI
- Device Name
- The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters. FDA UDI
Identifiers
- Catalog Number
- 8700-000831-01 FDA UDI
- Primary DI / UDI-DI
- 00849111075459 FDA UDI
- FDA Product Code
- NCX FDA UDI
- GMDN Term
- Intravascular core temperature regulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravascular core temperature regulation system
Rtx Circulating Cassette Without Electrolyte by ZOLL Circulation, 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
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI a189d871-8393-43c4-8232-f1502c13e7ce 36 fields · synced Jun 9, 2026