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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Lung donor-organ preservation/evaluation system chamber set | A collection of sterile devices intended to be used with a lung donor-organ preservation/evaluation system. It typically consists of a lung chamber with tubing and a fluid reservoir, oxygenator, leukocyte filter, pressure sensors and a connection for a ventilator with a humidity filter that creates an ex-vivo environment for the preservation, reconditioning and evaluation of the organs. It typically includes surgical drapes to create a sterile field for surgery. This is a single-use device. |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f61daf29-05e7-4c33-ba64-7779d2ab88e4
March 29, 2018
2
October 15, 2015
March 29, 2018
2
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
[?]
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