Identity
- Trade Name
- InnerCool RTx 10.7F Standard Catheter FDA UDI
- Generic Name
- Intravascular core temperature regulation system catheter FDA UDI
- Device Name
- An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter. FDA UDI
Identifiers
- Catalog Number
- 8700-000822-01 FDA UDI
- Primary DI / UDI-DI
- 00849111075381 FDA UDI
- 510(k) Number
- K080908 FDA UDI
- FDA Product Code
- NCX FDA UDI
- GMDN Term
- Intravascular core temperature regulation system catheter 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 65 Centimeter FDA UDICatheter Gauge — 10.7 French FDA UDI
Category: Intravascular core temperature regulation system catheter
InnerCool RTx 10.7F Standard Catheter by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular core temperature regulation system catheter.
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- Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) — ZOLL Circulation, Inc. · Class II
- QUATTRO® Intravascular Heat Exchange Catheter Kit Appluase (Heparin), Non Lidoca — ZOLL Circulation, Inc. · Class II
Cleared under the same submission
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 51372fd6-ddaf-4f48-bbb5-1a4a0b69c75a 38 fields · synced Jun 9, 2026