FDA.reportPublic FDA data

MICRO

Primary DI
08033178114608
Brand
MICRO
Company
SORIN GROUP ITALIA SRL
Model
40 µm Infant Arterial Filter
Published
2025-03-04
Public version status
New
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
K242092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242092000MICRO Arterial FiltersSorin Group Italia S.R.L.2024-11-18DTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178114609PackageGS16In Commercial Distribution
08033178114608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317811460938033178114609
08033178114608080331781146088033178114608

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
442126587
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

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
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
00643169767713Affinity Pixie™MEDTRONIC, INC.DTM2017-02-02