DEVICE: STEEN Solution™ (07350069520036)

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Device Identifier (DI) Information

STEEN Solution™
19004
19004
Xvivo Perfusion AB
07350069520036
GS1
1
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body 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
Yes
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
Donor-organ preservation solution A sterile solution intended to be used in conjunction with a donor-organ preservation/transport set for the flushing, transport, storage and preservation of donor organs (e.g., kidney, liver, heart, and pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain organ viability until the organ can be implanted in the recipient; the solution may be combined with blood. After application, this device cannot be reused.
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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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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store dark with the bottle in an up-right position
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 500 Milliliter
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Device Status

In Commercial Distribution
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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