Arterial cardiopulmonary bypass cannula

GUDID 10803622104227

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, arterial
Primary Device ID10803622104227
NIH Device Record Key8c78ef27-ef0f-4721-a72f-ac35422ac437
Commercial Distribution StatusIn Commercial Distribution
Brand NameArterial cardiopulmonary bypass cannula
Version Model NumberNA-xxxxx
Company DUNS080914995
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100803622104220 [Primary]
GS110803622104227 [Package]
Contains: 00803622104220
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 Date2015-07-17

On-Brand Devices [Arterial cardiopulmonary bypass cannula]

10803622106740RA-xxxxx
10803622106733NA-xxxxx
10803622106726NA-xxxxx
10803622106719NA-xxxxx
10803622106702NA-xxxxx
10803622106696NA-xxxxx
10803622106689NA-xxxxx
10803622106672NA-xxxxx
10803622106665NA-xxxxx
10803622106658NA-xxxxx
10803622105170RA-xxxxx
10803622105163RA-xxxxx
10803622105156RA-xxxxx
10803622105149RA-xxxxx
10803622105132RA-xxxxx
10803622105125RA-xxxxx
10803622105118RA-xxxxx
10803622105101RA-xxxxx
10803622105095RA-xxxxx
10803622105088RA-xxxxx
10803622105071RA-xxxxx
10803622105064RA-xxxxx
10803622105057RA-xxxxx
10803622105040RA-xxxxx
10803622105033RA-xxxxx
10803622105026RA-xxxxx
10803622105019RA-xxxxx
10803622105002RA-xxxxx
10803622104999RA-xxxxx
10803622104982RA-xxxxx
10803622104975RA-xxxxx
10803622104562NA-xxxxx
10803622104555NA-xxxxx
10803622104548NA-xxxxx
10803622104531NA-xxxxx
10803622104524NA-xxxxx
10803622104517NA-xxxxx
10803622104500NA-xxxxx
10803622104494NA-xxxxx
10803622104487NA-xxxxx
10803622104470NA-xxxxx
10803622104463NA-xxxxx
10803622104456NA-xxxxx
10803622104449NA-xxxxx
10803622104432NA-xxxxx
10803622104425NA-xxxxx
10803622104418NA-xxxxx
10803622104401NA-xxxxx
10803622104395NA-xxxxx
10803622104388NA-xxxxx

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