DEVICE: hilite (04250358151640)

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Device Identifier (DI) Information

hilite
hilite 1000 hollow fiber oxygenator for neonates and infants, model 0001
MW 6208 0001
Medos Medizintechnik Aktiengesellschaft
04250358151640
GS1
1
The Medos hilite 1000 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 1.0 liters per minute.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Extracorporeal membrane oxygenator A device designed for the extracorporeal diffusion of oxygen into the blood across a gas-permeable membrane used mainly during long-term surgery involving heart-lung bypass systems. It includes a membrane made of microporous polypropylene 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 hollow-fibre membrane oxygenator is the most common design and uses thousands of polypropylene or polyethylene (PE) capillary tubes to provide the blood/gas barrier. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTZ Oxygenator, Cardiopulmonary Bypass
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 30, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04250358153262 8 04250358151640 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
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No CLOSE

Customer Contact

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+49240296640
info@medos-ag.com
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