Aortic Arch Cannula

GUDID 10803622124409

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, arterial
Primary Device ID10803622124409
NIH Device Record Key0665c35c-b889-4aae-8f03-9f5279d28340
Commercial Distribution StatusIn Commercial Distribution
Brand NameAortic Arch Cannula
Version Model NumberNA-xxxxx
Company DUNS080914995
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622124402 [Primary]
GS110803622124409 [Package]
Contains: 00803622124402
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-15
Device Publish Date2015-07-23

On-Brand Devices [Aortic Arch Cannula]

10803622124416NA-xxxxx
10803622124409NA-xxxxx
10803622124393NA-xxxxx

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.