Cardioplegia Pack

GUDID 10803622149877

LIVANOVA USA, INC.

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Primary Device ID10803622149877
NIH Device Record Key70ca89a5-a342-49a1-a117-c650ccc606d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioplegia Pack
Version Model NumberCardioplegia Pack
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 Kittrue
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
GS100803622149870 [Primary]
GS110803622149877 [Package]
Contains: 00803622149870
Package: CASE [6 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-13
Device Publish Date2021-10-05

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