Drain Line

GUDID 10803622132138

LIVANOVA USA, INC.

Blood-processing autotransfusion system set
Primary Device ID10803622132138
NIH Device Record Key9302b1c0-919f-47ff-a924-bde4ddf42bf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrain Line
Version Model NumberDrain Line
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
GS100803622132131 [Primary]
GS110803622132138 [Package]
Contains: 00803622132131
Package: CASE [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

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 Date2016-06-03

Devices Manufactured by LIVANOVA USA, INC.

10803622158190 - Perfusion Pack2024-12-11
10803622158053 - Perfusion Pack2024-11-29
00803622158131 - Perfusion Pack2024-11-29
10803622158145 - Perfusion Pack2024-11-29
10803622158152 - Perfusion Pack2024-11-29
00803622158162 - Perfusion Pack2024-11-29
00803622158179 - Perfusion Pack2024-11-29
00803622158186 - Perfusion Pack2024-11-29

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