AccessGUDID - DEVICE: Terumo® Advanced Perfusion System 1 (00886799000588)

GUDID

Device Identifier (DI) Information

Brand Name: Terumo® Advanced Perfusion System 1
Version or Model: 801188
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 801188
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM.

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?
31714	Cardiopulmonary bypass system gas control unit	A device that is a module of a cardiopulmonary bypass system and that is used to control and measure the flow of gas supplied into the oxygenator. It is calibrated for a specific gas and has a high degree of accuracy at low flows. It may be a flowmeter.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTQ	Console, Heart-Lung Machine, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7ea585b-a06e-4f8b-9420-6dded2d2ea17
Public Version Date: August 21, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015