DEVICE: XVIVO Organ Chamber™ (07350069520074)

Device Identifier (DI) Information

XVIVO Organ Chamber™
19020
In Commercial Distribution
19020
Xvivo Perfusion AB
07350069520074
GS1

1
559895730 *Terms of Use
The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

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
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.
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FDA Product Code

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Product Code Product Code Name
PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0fd695a2-d991-4b00-97c0-96c317c35631
March 29, 2018
2
October 15, 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
No Package DIs found
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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
No
No CLOSE

Customer Contact

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+1 303 395 9171
info@xvivoperfusion.com
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