DEVICE: Novalung System (04057224902043)
Device Identifier (DI) Information
Novalung System
Novalung console
In Commercial Distribution
30000162
XENIOS AG
Novalung console
In Commercial Distribution
30000162
XENIOS AG
The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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33317 | Cardiopulmonary bypass system centrifugal pump drive unit |
A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K191407 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1c584ccd-bdb4-4ae5-90e6-a605d413a965
December 25, 2020
1
December 17, 2020
December 25, 2020
1
December 17, 2020
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined