Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer 8700-0781-14
GUDID 00849111075510
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| Primary Device ID | 00849111075510 |
| NIH Device Record Key | fc93be0b-3d35-4bce-a88e-a534a684242b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer |
| Version Model Number | CL-2295CO |
| Catalog Number | 8700-0781-14 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849111075510 [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 | 2015-06-30 |
Devices Manufactured by Zoll Circulation, Inc.
| 00849111076098 - STX SURFACE COOLING | 2024-08-23 STX Surface Cooling Pad |
| 00849111076104 - STX SURFACE COOLING | 2024-08-23 STX SURFACE COOLING Pad L/XL PAD SET |
| 00849111076111 - STX SURFACE COOLING | 2024-08-23 STX SURFACE COOLING Pad THIGHS ONLY PAD SET |
| 00849111076074 - Thermogard HQ Surface Start-Up Kit | 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac |
| 00849111076081 - ThermoGard XP Surface Start-Up Kit | 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac |
| 00849111076128 - Thermogard™ Vest, S/M | 2024-05-30 Thermogard™ Vest, S/M |
| 00849111076135 - Thermogard™ Vest, L/XL | 2024-05-30 Thermogard™ Vest, L/XL |
| 00849111075787 - Thermogard XP, Lang set C, Rohs | 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle |
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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