AccessGUDID - DEVICE: Hemotherm (10613031860221)

GUDID

Device Identifier (DI) Information

Brand Name: Hemotherm
Version or Model: 400CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 86022
Company Name: Gentherm Medical, LLC

Primary DI Number: 10613031860221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004249462 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWC	Controller, Temperature, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 50 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 60 Percent (%) Relative Humidity
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 7ee2a50e-65ed-460e-a56c-29a038bfe6d4
Public Version Date: September 23, 2021
Public Version Number: 5
DI Record Publish Date: October 06, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8009897373
Email: csz@genthermcsz.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES