Coronary sinus cannula

GUDID 10803622128162

LIVANOVA USA, INC.

Coronary sinus cannula
Primary Device ID10803622128162
NIH Device Record Keycd0b12a3-c3a1-4762-a89a-7871b35585bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoronary sinus cannula
Version Model NumberRC-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
GS100803622128165 [Primary]
GS110803622128162 [Package]
Contains: 00803622128165
Package: CASE [1 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 Date2015-09-17

On-Brand Devices [Coronary sinus cannula]

10803622128216RC-xxxxx
10803622128209RC-xxxxx
10803622128193RC-xxxxx
10803622128186RC-xxxxx
10803622128179RC-xxxxx
10803622128162RC-xxxxx
10803622128155RC-xxxxx
10803622128148RC-xxxxx
10803622128131RC-xxxxx
10803622128124RC-xxxxx
10803622105354RC-xxxxx
10803622105347RC-xxxxx
10803622105330RC-xxxxx
10803622105323RC-xxxxx
10803622105316RC-xxxxx
10803622105309RC-xxxxx
10803622105279RC-xxxxx
10803622105262RC-xxxxx
10803622105255RC-xxxxx
10803622105248RC-xxxxx
10803622105231RC-xxxxx
10803622105224RC-xxxxx
10803622105217RC-xxxxx
10803622105200RC-xxxxx
10803622105194RC-xxxxx
10803622105187RC-xxxxx

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