Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) 8700-0654-03
GUDID 00849111050074
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 | 00849111050074 |
| NIH Device Record Key | 6c55b00c-0db1-4615-bf75-62044b7861bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) |
| Version Model Number | N/A |
| Catalog Number | 8700-0654-03 |
| 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 |
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 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849111050074 [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 | 2015-03-31 |
On-Brand Devices [Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)]
| 00849111075060 | The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter design |
| 00849111050074 | The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter design |
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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