N/A

GUDID 00896208000559

Livanova Canada Corp

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis

Primary Device ID	00896208000559
NIH Device Record Key	dc87da04-1432-4f72-9b1b-3f4f5673e161
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	N/A
Company DUNS	243661431
Company Name	Livanova Canada Corp
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896208000559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P060038

FDA Product Code

LWR	heart-valve, non-allograft tissue

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-02-05
Device Publish Date	2016-08-08

Devices Manufactured by Livanova Canada Corp

00896208000078 - Mitroflow Aortic Handle	2021-04-16
00896208000214 - Mitroflow Accessory Tray	2021-04-16
08022057014924 - MITROFLOW VALSALVA CONDUIT	2021-02-05
08022057014931 - MITROFLOW VALSALVA CONDUIT	2021-02-05
08022057014948 - MITROFLOW VALSALVA CONDUIT	2021-02-05
08022057014955 - MITROFLOW VALSALVA CONDUIT	2021-02-05
00896208000092 - MITROFLOW	2021-02-05
00896208000108 - MITROFLOW	2021-02-05