AccessGUDID - DEVICE: HX2™ Temperature Management System (00886799000908)

GUDID

Device Identifier (DI) Information

Brand Name: HX2™ Temperature Management System
Version or Model: 809883
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 809883
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: HX2 Temperature Control System Accessory Hose Kit

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?
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 [?]
K071521	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea5f74c4-7a6a-4688-b2cc-472e1d1ded91
Public Version Date: December 23, 2019
Public Version Number: 5
DI Record Publish Date: September 24, 2015