RAP Femoral Venous Cannula

GUDID 10803622147149

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, femoral
Primary Device ID10803622147149
NIH Device Record Key9c363a6c-6376-489a-9379-d542ca84510c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAP Femoral Venous Cannula
Version Model Number200-150J
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
GS100803622147142 [Primary]
GS110803622147149 [Package]
Contains: 00803622147142
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

On-Brand Devices [RAP Femoral Venous Cannula]

10803622128094200-150
10803622128087200-100
10803622125802200-150
10803622125796200-100
10803622147149200-150J
10803622147217200-100J

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