| Primary Device ID | 00849111075558 |
| NIH Device Record Key | c8c48e7f-e257-4357-96a7-232259d6dd81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermogard XP, Lang set A, Non-Rohs, Refurb |
| Version Model Number | NA |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00849111075558 [Primary] |
| NCX | System, Hypothermia, Intravenous, Cooling |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-07-01 |
| 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 |