EasyFlow Duo Cannula

GUDID 10803622124188

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, arterial
Primary Device ID10803622124188
NIH Device Record Key9f9aa82f-7960-477e-9536-490771d3679f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyFlow Duo Cannula
Version Model NumberDuo Cannula
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
GS100803622124181 [Primary]
GS110803622124188 [Package]
Contains: 00803622124181
Package: CASE [5 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 Date2015-03-10

On-Brand Devices [EasyFlow Duo Cannula]

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10803622128070Duo Cannula
10803622124195Duo Cannula
10803622124188Duo Cannula
10803622147309Duo Cannula
10803622147279Duo Cannula
10803622147996Duo Cannula

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