FDA.reportPublic FDA data

LILLIPUT PMP

Primary DI
38033178112759
Brand
LILLIPUT PMP
Company
SORIN GROUP ITALIA SRL
Model
Oxygenator
Published
2015-11-25
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

Product Codes#

Code, Name table
CodeName
DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178112759PackageGS15In Commercial Distribution
08033178112758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317811275938033178112759
08033178112758080331781127588033178112758

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
38033178102934DHF02 HEMOCONCENTRATOR2015-07-15
38033178102941DHF06 HEMOCONCENTRATOR2015-07-15
38033178233638SH14 - HEMOCONCENTRATOR2015-07-15
38033178019621Aortic Root cannulaAR-131142026-03-06
38033178019638Aortic Root cannulaAR-191142026-03-06
38033178019645Vessel CannulaVC-120002026-03-06
38033178019652Vessel CannulaVC-120102026-03-06
38033178019669Vessel CannulaVC-120202026-03-06
38033178019676Vessel CannulaVC-220102026-03-06
38033178017191Cardioplegia CannulaAR-110122026-02-11
38033178017207Cardioplegia CannulaAR-110142026-02-11
38033178017214Cardioplegia CannulaAR-110162026-02-11
38033178017221Cardioplegia CannulaAR-110182026-02-11
38033178017238Cardioplegia CannulaAR-111122026-02-11
38033178017245Cardioplegia CannulaAR-111142026-02-11
38033178017252Cardioplegia CannulaAR-111162026-02-11
38033178017269Cardioplegia CannulaAR-170122026-02-11
38033178017276Cardioplegia CannulaAR-170142026-02-11
38033178017313Cardioplegia CannulaAX-303212026-02-11
38033178018075Coronary Sinus CannulaRCM-141152026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160301796Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2SPECTRUM MEDICAL SRLDTZ2025-09-11
18052705493358A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
18052705493365AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
05060912587483CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTZ2025-02-07
08051160300709Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2024-11-19
08051160300761Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2024-11-19
18051160301864Quantum Perfusion Blood Oxygenator VT75-E1SPECTRUM MEDICAL SRLDTZ2024-11-05
18051160301871Quantum Perfusion Blood Oxygenator VT75-E2SPECTRUM MEDICAL SRLDTZ2024-11-05
15060491619817CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTZ2024-10-07
00763000765750Affinity Fusion®MEDTRONIC, INC.DTZ2024-08-12
38033178112841KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
38033178113473KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
18051160301840Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1USPECTRUM MEDICAL SRLDTZ2024-01-12
18051160301857Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2USPECTRUM MEDICAL SRLDTZ2024-01-12
15060491614126Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCHALICE MEDICAL LIMITEDDTZ2023-11-07
00763000834210Affinity Fusion™MEDTRONIC, INC.DTZ2023-08-04
00813502013184Abiomed Breethe OXY-1 SystemBreethe, Inc.DTZ2023-06-02
00813502013245Abiomed Breethe OXY-1 SystemBreethe, Inc.DTZ2023-06-02
00813502012354Abiomed Breethe OXY-1 SystemBreethe, Inc.DTZ2023-05-26
00813502012361Abiomed Breethe OXY-1 SystemBreethe, Inc.DTZ2023-05-26
00860001797985Abiomed Breethe OXY-1 SystemBreethe, Inc.DTZ2023-05-26
18051160302151Quantum PureFlow Standard Heat Exchanger Low Flow 3/8QURA SRLDTZ2023-05-04
08051160301423Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1UQURA SRLDTZ2022-02-16
08051160301430Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2UQURA SRLDTZ2022-02-16
08051160301447Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1UQURA SRLDTZ2022-02-16
08051160301454Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2UQURA SRLDTZ2022-02-16
08051160300679Quantum Perfusion Blood Oxygenator ECC VT200-E1QURA SRLDTZ2021-12-23
08051160300686Quantum Perfusion Blood Oxygenator ECC VT200-E2QURA SRLDTZ2021-12-23
08051160300730Quantum Perfusion Blood Oxygenator ECC VT160-E1QURA SRLDTZ2021-12-23
08051160300747Quantum Perfusion Blood Oxygenator ECC VT160-E2QURA SRLDTZ2021-12-23