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Terumo® PALL Arterial Filter

Primary DI
00699753450011
Brand
Terumo® PALL Arterial Filter
Company
Terumo Cardiovascular Systems Corporation
Model
AL6X
Published
2016-03-14
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

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
K083834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083834000TERUMO PALL AL6X ARTERIAL FILTERTerumo Cardiovascular Systems Corp.2009-04-17DTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450016PackageGS110In Commercial Distribution
00699753450011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345001650699753450016
00699753450011006997534500116997534500110699753450011

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.

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753538177Cardiovascular Procedure Kit76754-012026-10-22
00699753538184Cardiovascular Procedure Kit788202026-10-22
00699753538191Cardiovascular Procedure KitCX-UK7722026-10-22
00699753538061Cardiovascular Procedure KitCX-CZ227X2026-10-09
00699753538078Cardiovascular Procedure KitCX-CZ2282026-10-09
00699753538085Cardiovascular Procedure KitCX-SP296X2026-10-09
00699753538092Cardiovascular Procedure KitCX-SP297X2026-10-09
00699753538108Cardiovascular Procedure Kit787582026-10-09
00699753538115Cardiovascular Procedure Kit788232026-10-09
00699753538122Cardiovascular Procedure Kit787472026-10-09
00699753538139Cardiovascular Procedure Kit787482026-10-09
00699753538146Cardiovascular Procedure Kit787442026-10-09
00699753538153Cardiovascular Procedure Kit787462026-10-09
00699753538160Cardiovascular Procedure Kit787452026-10-09
00699753538054Cardiovascular Procedure Kit786082026-09-24
00699753537880Cardiovascular Procedure Kit788312026-08-26
00699753537897Cardiovascular Procedure Kit788332026-08-26
00699753537903Cardiovascular Procedure KitCX-CZ226X2026-08-26
00699753537910Cardiovascular Procedure KitCX-UK7672026-08-26
00699753537927Cardiovascular Procedure KitCX-UK7682026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117378264HORIZON 8AFEUROSETS SRLDTM2026-10-15
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