Identity
- Trade Name
- Sarns™ Temperature Control Module FDA UDI
- Generic Name
- Cardiopulmonary bypass system heating/cooling unit FDA UDI
- Device Name
- TCM II Cooling/Heating System FDA UDI
- Model / Reference
- 4415 FDA UDI
- Description
- TCM II Cooling/Heating System FDA UDI
Identifiers
- Catalog Number
- 4415 FDA UDI
- Primary DI / UDI-DI
- 00886799000014 FDA UDI
- 510(k) Number
- K883603 FDA UDI
- FDA Product Code
- DWC FDA UDI
- GMDN Term
- Cardiopulmonary bypass system heating/cooling unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4250 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
Yes
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
Category: Cardiopulmonary bypass system heating/cooling unit
Sarns™ Temperature Control Module by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system heating/cooling unit.
- CardioQuip Refrigeration Module — CardioQuip · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Heater-Cooler System — LivaNova Deutschland GmbH · Class II
- CardioQuip Thermoelectric Cooling (TEC) Lid Module — CardioQuip · Class II
- Hemotherm — Gentherm Medical, LLC · Class II
- Heater-Cooler System — LivaNova Deutschland GmbH · Class II
- Heater-Cooler — LivaNova Deutschland GmbH · Class II
- Heater-Cooler System — LivaNova Deutschland GmbH · Class II
Cleared under the same submission
K883603 also covers:
- Sarns™ Temperature Control Module — Terumo Cardiovascular Systems Corporation
- Sarns™ Temperature Control Module — Terumo Cardiovascular Systems Corporation
- Sarns™ Temperature Control Module — Terumo Cardiovascular Systems Corporation
- Sarns™ Temperature Control Module — Terumo Cardiovascular Systems Corporation
- Sarns™ Temperature Probe Module — Terumo Cardiovascular Systems Corporation
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
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI 35ef4f3f-c498-40b8-a275-dc9a6bbb71a8 35 fields · synced Jun 9, 2026