FDA.reportPublic FDA data

hilite

Primary DI
04250358151602
Brand
hilite
Company
Medos Medizintechnik Aktiengesellschaft
Model
hilite 7000 hollow fiber oxygenator, model 0061
Catalog number
MW 6202 0061
Device description
The Medos hilite 7000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute.
Published
2015-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
04250358153217PackageGS18In Commercial Distribution
04250358151602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250358153217042503581532174250358153217
04250358151602042503581516024250358151602

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49240296640info@medos-ag.com

Regulatory Flags#

DUNS number
313013477
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250358151626hilitehilite 2800 hollow fiber oxygenator for pediatricsMW 6205 00012015-09-30
04250358151633hilitehilite 2400 LT hollow fiber oxygenator for pediatrMW 6205 0L012015-09-30
04250358151640hilitehilite 1000 hollow fiber oxygenator for neonates aMW 6208 00012015-09-30
04250358151657hilitehilite 800 LT hollow fiber oxygenator for neonatesMW 6208 0L012015-09-30
04250358151619hilitehilite 7000 LT hollow fiber oxygenator, model 0L61MW 6202 0L612015-09-30
04250358150070hilitehilite MVC 4030 hardshell venous reservoirMW 6221 01002016-09-24
04250358153248hilitehilite 2800 hollow fiber oxygenator for pediatricsMW 6205 00012015-09-30
04250358153255hilitehilite 2400 LT hollow fiber oxygenator for pediatrMW 6205 0L012015-09-30
04250358153262hilitehilite 1000 hollow fiber oxygenator for neonates aMW 6208 00012015-09-30
04250358153279hilitehilite 800 LT hollow fiber oxygenator for neonatesMW 6208 0L012015-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
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
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178112840KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113342INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08052705496253A.M.G. PP SterileEUROSETS SRLDTZ2020-05-11
08033178113182INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113212INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113236INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08034013782020A.M.G. PMP SterileEUROSETS SRLDTZ2017-02-28
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