Hemotherm

Basic Information

• Brand Name: Hemotherm
• Primary DI: 10613031860221
• Version / Model: 400CE
• Catalog Number: 86022
• Company Name: Gentherm Medical, LLC
• Labeler DUNS: 004249462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-06
• Public Version: 5
• Public Version Date: 2021-09-23
• Public Version Status: Update
• Public Device Record Key: 7ee2a50e-65ed-460e-a56c-29a038bfe6d4

Device Description

Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	870.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17206	Cardiopulmonary bypass system heating/cooling unit	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10613031860221	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	32	Inch
Depth	22	Inch
Width	22	Inch
Weight	198	Pound
Area/Surface Area	484	Square inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity