AccessGUDID - DEVICE: Sarns™ Modular Perfusion System 8000 (00886799000236)

GUDID

Device Identifier (DI) Information

Brand Name: Sarns™ Modular Perfusion System 8000
Version or Model: 16418
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16418
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: Line Occluder

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?
36347	Cardiopulmonary bypass system roller pump	A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSJ	Alarm, Blood-Pressure
DSK	Computer, Blood-Pressure
DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type
KRL	Detector, Bubble, Cardiopulmonary Bypass
KRI	Accessory Equipment, Cardiopulmonary Bypass
DWC	Controller, Temperature, Cardiopulmonary Bypass
DWA	Control, Pump Speed, Cardiopulmonary Bypass
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960916	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: 420ba397-cdc9-4369-a852-f13edcacd5a6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016