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Hemotherm

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Hemotherm FDA UDI
Generic Name
Cardiopulmonary bypass system heating/cooling unit FDA UDI
Device Name
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz) FDA UDI
Model / Reference
400CE FDA UDI
Description
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz) FDA UDI

Identifiers

Catalog Number
86022 FDA UDI
Primary DI / UDI-DI
10613031860221 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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 32 Inch FDA UDI
Depth — 22 Inch FDA UDI
Width — 22 Inch FDA UDI
Weight — 198 Pound FDA UDI
Area/Surface Area — 484 Square inch FDA UDI

Category: Cardiopulmonary bypass system heating/cooling unit

Hemotherm by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system heating/cooling unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentherm Medical, LLC

Sources (1)

  • FDA UDI 7ee2a50e-65ed-460e-a56c-29a038bfe6d4 37 fields · synced May 30, 2026