Prime Set

GUDID 10803622128360

LIVANOVA USA, INC.

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Primary Device ID10803622128360
NIH Device Record Key64cca759-e637-49fb-b1b1-5247738302af
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrime Set
Version Model NumberAX-xxxxx
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
GS100803622128363 [Primary]
GS110803622128360 [Package]
Contains: 00803622128363
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 Date2015-09-22

Devices Manufactured by LIVANOVA USA, INC.

10803622156509 - Cardioplegia Pack2024-04-23
10803622156516 - Cardioplegia Pack2024-04-23
00803622156526 - Perfusion Pack2024-04-23
00803622156533 - Perfusion Pack2024-04-23
00803622156540 - Perfusion Pack2024-04-23
10803622156554 - Perfusion Pack2024-04-23
10803622156561 - Perfusion Pack2024-04-23
10803622156592 - Cardioplegia Pack2024-04-23

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