FDA.reportPublic FDA data

INSPIRE

Primary DI
08033178113359
Brand
INSPIRE
Company
SORIN GROUP ITALIA SRL
Model
7F
Published
2021-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTMFilter, blood, cardiopulmonary bypass, arterial line
DTNReservoir, blood, cardiopulmonary bypass
DTPDefoamer, cardiopulmonary bypass
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

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
38033178113350PackageGS12In Commercial Distribution
08033178113359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317811335038033178113350
08033178113359080331781133598033178113359

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.

Contacts#

Phone, Email table
PhoneEmail
+39053529811XX@XX.XX

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
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
06974762681019LifemotionLifemotion Medical Technology Co., Ltd.DTZ2026-06-02
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372446TRILLYEUROSETS SRLDTM2026-05-05
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
B00962623OCS HEART LEUKOCYTE DEPLETING FILTERTRANSMEDICS, INC.DTM2026-05-04
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114561MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114578MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114608MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20