AccessGUDID - DEVICE: Sarns™ Modular Perfusion System 8000 (00886799000205)

GUDID

Device Identifier (DI) Information

Brand Name: Sarns™ Modular Perfusion System 8000
Version or Model: 16413
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16413
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: 8000 Perfusion System Arterial Monitor Providing Temperature and Pressure Measurement Display.

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?
36374	Cardiopulmonary bypass system temperature control unit	An electronic device that is a module of a cardiopulmonary bypass system and that is used to measure and display the temperatures of the different temperature probes that are connected into the total system in order to monitor the fluid and blood temperatures at various points. It may also control the temperature levels, e.g., the temperature level of the fluid entering and leaving the heat exchanger.	Active	false
36356	Cardiopulmonary bypass system pressure monitor	A mains electricity (AC-powered) device used to electronically measure the pressure in a cardiopulmonary bypass system (e.g., in the extracorporeal tubing circuit); it may provide an alarm if pressure levels exceed operator-set limits. It is typically a module of the heart-lung bypass system.	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 [?]
K915183	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: 6187842a-cc60-4ad8-bb6f-21b4e7c52a5a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015