Sarns™ Modular Perfusion System 8000

Basic Information

• Brand Name: Sarns™ Modular Perfusion System 8000
• Primary DI: 00886799000236
• Version / Model: 16418
• Catalog Number: 16418
• 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: 420ba397-cdc9-4369-a852-f13edcacd5a6

Device Description

Line Occluder

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: Yes
• Has Lot/Batch Number: No
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886799000236	GS1

Premarket Submissions

Submission Number	Supplement Number
K960916	000