Sarns™ Modular Perfusion System 8000

Basic Information

• Brand Name: Sarns™ Modular Perfusion System 8000
• Primary DI: 00886799000342
• Version / Model: 147361
• Catalog Number: 147361
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c659827f-3474-412c-887a-7127f0b3d12f

Device Description

Flow meter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSJ	Alarm, Blood-Pressure	Cardiovascular	870.1100	2
DSK	Computer, Blood-Pressure	Cardiovascular	870.1110	2
DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type	Cardiovascular	870.4370	2
KRL	Detector, Bubble, Cardiopulmonary Bypass	Cardiovascular	870.4205	2
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	870.4200	1
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	870.4250	2
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	870.4380	2
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	Cardiovascular	870.4340	2
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	870.4220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886799000342	GS1

Premarket Submissions

Submission Number	Supplement Number
K960916	000