DEVICE: XVIVO PGM Disposable Sensors™ (07350069520111)
Device Identifier (DI) Information
XVIVO PGM Disposable Sensors™
19033
In Commercial Distribution
19033
Xvivo Perfusion AB
19033
In Commercial Distribution
19033
Xvivo Perfusion AB
The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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58267 | Lung donor-organ preservation/evaluation system lung-interface set |
A collection of disposable devices intended to be used with a lung donor-organ preservation/evaluation system to house, supply oxygen to, and/or manage preservation solution for, the preserved lung(s). It typically consists of the following components: a lung chamber, breathing circuit tubing, a configuration of fluid delivery tubing, a fluid reservoir, oxygenator components, filter(s), sensors, and may also include surgical drapes. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f61daf29-05e7-4c33-ba64-7779d2ab88e4
December 22, 2021
4
October 15, 2015
December 22, 2021
4
October 15, 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
[?]
+1 303 395 9171
info@xvivoperfusion.com
info@xvivoperfusion.com