hilite

Primary DI
04250358153279
Brand
hilite
Company
Medos Medizintechnik Aktiengesellschaft
Model
hilite 800 LT hollow fiber oxygenator for neonates
Catalog number
MW 6208 0L01
Device description
The Medos hilite 800 LT 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 0.2 to 0.8 liters per minute.
Published
2015-09-30
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
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250358153279PackageGS18In Commercial Distribution
04250358151657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250358153279042503581532794250358153279
04250358151657042503581516574250358151657

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
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
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
04250358151602hilitehilite 7000 hollow fiber oxygenator, model 0061MW 6202 00612015-09-30
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

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