Identity
- Trade Name
- Thermogard XP, Lang set C, Rohs FDA UDI
- Generic Name
- Intravascular core temperature regulation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ThermogardHQ, Lang set C FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 601337-001 FDA UDI
- Primary DI / UDI-DI
- 00849111075787 FDA UDI
- 510(k) Number
- K072234 FDA UDI
- FDA Product Code
- NCX FDA UDI
- GMDN Term
- Intravascular core temperature regulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Intravascular core temperature regulation system
Thermogard XP, Lang set C, Rohs by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular core temperature regulation system.
- Thermogard XP® — ZOLL Circulation, Inc. · Class II
- Thermogard HQTM Console — ZOLL Circulation, Inc. · Class II
- Thermogard XP, Lang set C, Rohs, Refurb — ZOLL Circulation, Inc. · Class II
- Thermogard XP, Lang set A, Rohs, Refurb — ZOLL Circulation, Inc. · Class II
- Thermogard XP® — ZOLL Circulation, Inc. · Class II
- Thermogard XP® — ZOLL Circulation, Inc. · Class II
- Hospital Monitoring Interface Accessory — ZOLL Circulation, Inc. · Class II
- RTX CIRCULATING CASSETTE WITH ELECTROLYTE — ZOLL Circulation, Inc. · Class II
Cleared under the same submission
K072234 also covers:
- Hospital Monitoring Interface Accessory — ZOLL Circulation, Inc.
- Hospital Monitoring Interface Accessory — ZOLL Circulation, Inc.
- Thermogard XP, Lang set A, Non-Rohs, Refurb — ZOLL Circulation, Inc.
- Thermogard XP, Lang set A, Rohs, Refurb — ZOLL Circulation, Inc.
- Thermogard XP, Lang set B, Rohs, Refurb — ZOLL Circulation, Inc.
- Thermogard XP, Lang set C, Rohs, Refurb — ZOLL Circulation, Inc.
- Thermogard XP® — ZOLL Circulation, Inc.
- Thermogard XP® — ZOLL Circulation, Inc.
- Thermogard XP® — ZOLL Circulation, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI a4cb74fb-8810-4354-bbed-9ffcd56a2efa 36 fields · synced Jun 9, 2026