Identity
- Trade Name
- 10.7F PACKAGED ACCUTROL CATHETER FDA UDI
- Generic Name
- Intravascular core temperature regulation system catheter FDA UDI
- Device Name
- The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE). FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE). FDA UDI
Identifiers
- Catalog Number
- 8700-000824-01 FDA UDI
- Primary DI / UDI-DI
- 00849111075404 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
10.7f Packaged Accutrol Catheter by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intravascular core temperature regulation system catheter.
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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 05d78c94-f128-42b4-8ea4-547dd318b03b 38 fields · synced Jun 9, 2026