Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin 8700-0781-01
GUDID 00849111075190
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.
Zoll Circulation, Inc.
Intravascular heating/cooling system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter| Primary Device ID | 00849111075190 |
| NIH Device Record Key | 2721536e-4ddd-4cd3-8e31-36fe4033885b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin |
| Version Model Number | CL-2295 |
| Catalog Number | 8700-0781-01 |
| Company DUNS | 799455241 |
| Company Name | Zoll Circulation, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com | |
| Phone | 4085412140 |
| udisj@zoll.com |
Device Dimensions
| Catheter Gauge | 9.3 French |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
| Length | 22 Centimeter |
| Catheter Gauge | 9.3 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849111075190 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101987
FDA Product Code
| NCX | System, Hypothermia, Intravenous, Cooling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-07-30 |
Devices Manufactured by Zoll Circulation, Inc.
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| 00849111075794 - Thermogard XP, Lang set C, Rohs, Refurb | 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle |
| 00849111002998 - AutoPulse Li-ion Battery | 2023-10-25 Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform System. |
| 00849111003032 - AutoPulse NXT | 2023-10-25 AutoPulse NXT Quick Case. |
| 10849111002988 - LifeBand® Load-distributing Band | 2023-10-25 Single-use chest compression band. (3 per package) |
| 00849111002981 - LifeBand® Load-distributing Band | 2023-10-24 Single-use chest compression band. |
| 00849111003018 - AutoPulse NXT Resuscitation System | 2023-10-23 A Battery Charger is a standalone unit intended to charge and test-cycle the Nickel Metal Hydride Batteries. |
| 00849111003025 - AutoPulse NXT Resuscitation System | 2023-10-23 Shoulder Restraint English |
Trademark Results [Cool Line]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOL LINE 78751430 not registered Dead/Abandoned |
Single Buoy Moorings Inc. 2005-11-10 |
 COOL LINE 77514164 3668415 Dead/Cancelled |
Yamuna International 2008-07-03 |
 COOL LINE 75604187 2858190 Live/Registered |
ZOLL CIRCULATION, INC. 1998-12-09 |
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