DEVICE: sLA Membrane Lung (04260058550711)
Device Identifier (DI) Information
sLA Membrane Lung
Novalung® Surgical Lung Assist (sLA) MembraneLung TM
In Commercial Distribution
8800076
novalung GmbH
Novalung® Surgical Lung Assist (sLA) MembraneLung TM
In Commercial Distribution
8800076
novalung GmbH
The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffusion across a polymethylpentene (PMP) hollow fibre membrane material. Used in conjunction with a heart-lung machine along with a separate venous reservoir and heat exchanger, the sLA Membrane Lung can be used in open-heart surgery.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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. |
FDA Product Code
[?]Product Code | Product Code Name |
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DTZ | Oxygenator, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K072362 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 0,5-4,5 liter per minute |
Device Record Status
64b61b85-ba44-40aa-9e82-943f7273e039
July 06, 2018
3
September 30, 2015
July 06, 2018
3
September 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49713127060
info@novalung.com
info@novalung.com