FDA.reportPublic FDA data

INSPIRE

Primary DI
38033178113343
Brand
INSPIRE
Company
SORIN GROUP ITALIA SRL
Model
7F M
Published
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K200683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200683000INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoirSorin Group Italia S.R.L.2020-06-12DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178113343PackageGS12In Commercial Distribution
08033178113342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317811334338033178113343
08033178113342080331781133428033178113342

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
442126587
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178018203Venous Cardiopolmunary Bypass CannulaRDS-610342025-12-19
08033178018227Venous Cardiopolmunary Bypass CannulaRDS-610402025-12-19
08033178018234Venous Cardiopolmunary Bypass CannulaRDS-610462025-12-19
08033178018258Venous Cardiopolmunary Bypass CannulaRDS-611342025-12-19
08033178018272Venous Cardiopolmunary Bypass CannulaRDS-611402025-12-19
08033178018289Venous Cardiopolmunary Bypass CannulaRDS-611462025-12-19
08033178018296Venous Cardiopolmunary Bypass CannulaRDS-611502025-12-19
08033178018364Venous Cardiopolmunary Bypass CannulaRV-400162025-12-19
08033178018371Venous Cardiopolmunary Bypass CannulaRV-400182025-12-19
08033178018388Venous Cardiopolmunary Bypass CannulaRV-400202025-12-19
08033178018395Venous Cardiopolmunary Bypass CannulaRV-400222025-12-19
08033178018401Venous Cardiopolmunary Bypass CannulaRV-400242025-12-19
08033178018418Venous Cardiopolmunary Bypass CannulaRV-400262025-12-19
08033178018425Venous Cardiopolmunary Bypass CannulaRV-400282025-12-19
08033178018432Venous Cardiopolmunary Bypass CannulaRV-400302025-12-19
08033178018449Venous Cardiopolmunary Bypass CannulaRV-400322025-12-19
08033178018456Venous Cardiopolmunary Bypass CannulaRV-400342025-12-19
08033178018463Venous Cardiopolmunary Bypass CannulaRV-400362025-12-19
08033178018487Venous Cardiopolmunary Bypass CannulaRV-405362025-12-19
08033178018524Venous Cardiopolmunary Bypass CannulaRV-410182025-12-19

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
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