FDA.reportPublic FDA data

Pall LeukoGuard LG

Primary DI
05034480000392
Brand
Pall LeukoGuard LG
Company
Pall International Sàrl
Model
LG6
Catalog number
LG6
Device description
Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTMFilter, blood, cardiopulmonary bypass, arterial line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902518000LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICEPall Biomedical Products Co.1990-10-16DTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480000393PackageGS16In Commercial Distribution
05034480000392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448000039335034480000393
05034480000392050344800003925034480000392

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system filter, arterial blood lineA sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Pore Size40Micrometer

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578EURegulatory@europe.pall.com

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05034480310125Pall PharmAssure® 25 mm Hydrophobic Vent FilterHP2002HP20022016-07-27
05034480000408Pall LeukoGuard LGLG6BLG6B2015-10-21
05034480000446Pall® Oxygenator Gas Line FilterORO1HORO1H2016-07-20
05034480104373Pall Supor® AEF FilterAEF1EAEF1E2016-07-20
05034480306104Pall LeukoGuard BC2BC2BBC2B2015-10-21
05034480308825Pall Supor® AEF FilterAEF1NTEAEF1NTE2016-07-20
05034480308979Pall LaparoShield® Plus Laparoscopic Smoke Filtration SystemLSF1LSF12016-07-20
05034480309143Pall® Pro-Tec Filter for Pulmonary Function TestingPF30SPF30S2016-07-20
05034480310170Pall PharmAssure® Syringe FilterHP4648HP46482024-03-15
05034480313553Pall-Aquasafe™ Water FilterAQF4AAQF4A2016-07-20
05034480313690Pall-Aquasafe™ Water FilterAQ31F1SAAQ31F1SA2016-07-20
05034480313744Pall-Aquasafe™ Water FilterAQ31F1RAAQ31F1RA2016-07-20
05034480313751Pall-Aquasafe™ Water FilterAQINAAQINA2016-07-20
05034480314147Pall LaparoShield® Plus Laparoscopic Smoke FilterLSF2LSF22016-07-20
05034480314802Pall-Aquasafe™ Detachable Shower RoseAQROSEAAQROSEA2016-07-20
05034480315106Pall625418562541852015-10-21
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20
05034480315533Pall QPoint® Filter CapsuleQR22AQR22A2017-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
B00962623OCS HEART LEUKOCYTE DEPLETING FILTERTRANSMEDICS, INC.DTM2026-05-04
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114561MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114578MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114608MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114562MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114579MICROSORIN GROUP ITALIA SRLDTM2025-03-04
38033178114609MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178113342INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
38033178113343INSPIRESORIN GROUP ITALIA SRLDTM2021-04-13
04037691180038PLEGIOX Heat Exchanger with CardioplegiaMaquet Cardiopulmonary AGDTM2017-05-02
04037691253862QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691173412QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691117911QUARTMaquet Cardiopulmonary AGDTM2017-03-13
04037691229591PLEGIOX Cardioplegia Heat Exchanger Maquet Cardiopulmonary AGDTM2017-03-13
04058863017341QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863017372QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019055QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019079QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019147QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019185QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019000QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019024QUADROX-iDMaquet Cardiopulmonary AGDTM2017-02-16
04058863019154QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16
04058863019178QUADROX-iMaquet Cardiopulmonary AGDTM2017-02-16