Venous cardiopulmonary bypass cannula

GUDID 10803622104876

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, venous
Primary Device ID10803622104876
NIH Device Record Key5b10f3ff-6473-4787-87e7-0a87586964e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenous cardiopulmonary bypass cannula
Version Model NumberNV-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
GS100803622104879 [Primary]
GS110803622104876 [Package]
Contains: 00803622104879
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 Date2015-07-15

On-Brand Devices [Venous cardiopulmonary bypass cannula]

10803622128278RT-xxxxx
00803622128264RT-xxxxx
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10803622105514RT-xxxxx
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10803622105477RD-xxxxx
10803622105460RD-xxxxx
10803622105453RD-xxxxx
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10803622105439RD-xxxxx

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