Pall LeukoGuard LG LG6B

GUDID 35034480000409

Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with Bypass Loop)

Pall International Sàrl

Cardiopulmonary bypass system filter, arterial blood line
Primary Device ID35034480000409
NIH Device Record Key067e92c6-b2d1-46c6-ba0b-84833fa811e0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePall LeukoGuard LG
Version Model NumberLG6B
Catalog NumberLG6B
Company DUNS485050483
Company NamePall International Sàrl
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)645-6578
EmailEURegulatory@europe.pall.com

Device Dimensions

Device Size Text, specify0
Pore Size40 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS105034480000408 [Primary]
GS135034480000409 [Package]
Contains: 05034480000408
Package: case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTMFilter, blood, cardiopulmonary bypass, arterial line

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[35034480000409]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-21

On-Brand Devices [Pall LeukoGuard LG]

35034480000409Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with By
35034480000393Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service

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