FDA.reportPublic FDA data

Hemotherm

Primary DI
10613031860221
Brand
Hemotherm
Company
Gentherm Medical, LLC
Model
400CE
Catalog number
86022
Device description
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)
Published
2015-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWCController, Temperature, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10613031860221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061303186022110613031860221

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heating/cooling unitA mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area484Square inch
Depth22Inch
Height32Inch
Weight198Pound
Width22Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8009897373csz@genthermcsz.com

Regulatory Flags#

DUNS number
004249462
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10613031871074Blanketrol233871072024-06-25
20613031838739Maxi-Therm Lite 873-USME873-USME2024-05-13
20613031838746Maxi-Therm Lite 874-USME874-USME2024-05-13
20613031838760Maxi-Therm Lite 876-USME876-USME2024-05-13
20613031839002Kool-Kit 900-USME900-USME2024-05-13
20613031839200Kool-Kit 920-USME920-USME2024-05-13
20613031839309Kool-Kit 930-USME930-USME2024-05-13
20613031839507Kool-Kit 950-USME950-USME2024-05-13
10613031873078Blanketrol2332332024-05-13
10613031838732Maxi-Therm Lite 873-USME873-USME2024-05-13
10613031838749Maxi-Therm Lite 874-USME874-USME2024-05-13
10613031838763Maxi-Therm Lite 876-USME876-USME2024-05-13
10613031839005Kool-Kit 900-USME900-USME2024-05-13
10613031839203Kool-Kit 920-USME920-USME2024-05-13
10613031839302Kool-Kit 930-USME930-USME2024-05-13
10613031839500Kool-Kit 950-USME950-USME2024-05-13
20613031812432FilteredFlo® PACU Adult Blanket243812432022-08-22
20613031812449FilteredFlo® Pediatric Blanket244812442022-08-22
20613031832430FilteredFlo® PACU Adult Blanket243832432017-08-30
20613031832461FilteredFlo® Neonate/Pediatric Blanket246832462022-08-22

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Primary DI, Brand, Company table
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