AccessGUDID - DEVICE: InnerCool® STx™ System (10613031860009)

GUDID

Device Identifier (DI) Information

Brand Name: InnerCool® STx™ System
Version or Model: 25-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 86000
Company Name: Gentherm Medical, LLC

Primary DI Number: 10613031860009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004249462 *Terms of Use

Device Description: Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
36956	External circulating-fluid core temperature regulation system control unit, heating/cooling	An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

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 122 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 50 Degrees Celsius
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 131 Pound
Height: 37.5 Inch
Depth: 17.0 Inch
Width: 17.0 Inch

Device Record Status

Public Device Record Key: cd715d2d-021c-4920-a324-ee89e9073f89
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: August 26, 2016