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Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) FDA UDI
- Generic Name
- Intravascular core temperature regulation system catheter FDA UDI
- Device Name
- The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins. FDA UDI
- Model / Reference
- CL-2295AE FDA UDI
- Description
- The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins. FDA UDI
Identifiers
- Catalog Number
- 8700-0654-40 FDA UDI
- Primary DI / UDI-DI
- 00849111075060 FDA UDI
- 510(k) Number
- K101987 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 22 Centimeter FDA UDICatheter Gauge — 9.3 French FDA UDI
Category: Intravascular core temperature regulation system catheter
Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Intravascular core temperature regulation system catheter.
- Quattro, Japan, Final Packaged Kit (Applause) — ZOLL Circulation, Inc. · Class II
- QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) — ZOLL Circulation, Inc. · Class II
- QUATTRO® Intravascular Heat Exchange Catheter Kit Surmodics Non-Heparin — ZOLL Circulation, Inc. · Class II
- ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin) — ZOLL Circulation, Inc. · Class II
- InnerCool RTx 10.7F Standard Catheter — ZOLL Circulation, Inc. · Class II
- SOLEX® Intravascular Heat Exchange Catheter EU Kit Applause (Heparin) — ZOLL Circulation, Inc. · Class II
- SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause Hep — 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
K101987 also covers:
- Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit (Non Heparin) — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit Applause (Heparin) — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit Custom — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom Luer — ZOLL Circulation, Inc.
- Cool Line® Intravascular Heat Exchange Catheter Kit US (Surmodics Non-Lidocaine) — ZOLL Circulation, Inc.
- ICY-3, Japan, Final Packaged Kit (Applause) — ZOLL Circulation, Inc.
- ICY® Intravascular Heat Exchange Catheter Kit (Heparin) — ZOLL Circulation, Inc.
- ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) — ZOLL Circulation, 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
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI d648d176-2db5-4a09-976d-87e641d7be26 37 fields · synced Jun 9, 2026