Thermogard XP®
GUDID 00849111075015
The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
Zoll Circulation, Inc.
Intravascular heating/cooling system| Primary Device ID | 00849111075015 |
| NIH Device Record Key | 2f038c80-b3ca-415c-b936-0095c6341dee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermogard XP® |
| Version Model Number | Thermogard XP, Lang set A, Rohs |
| Company DUNS | 799455241 |
| Company Name | Zoll Circulation, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849111075015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072234
FDA Product Code
| NCX | System, Hypothermia, Intravenous, Cooling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
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 [Thermogard XP®]
| 00849111075022 | The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature |
| 00849111075015 | The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature |
| 00849111075008 | The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature |
Trademark Results [Thermogard XP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMOGARD XP 77088799 3528160 Live/Registered |
ZOLL CIRCULATION, INC. 2007-01-23 |
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