DEVICE: XVIVO Perfusion System (XPS™) (07350069520104)

Download: XML | JSON

Device Identifier (DI) Information

XVIVO Perfusion System (XPS™)
19030
19030
Xvivo Perfusion AB
07350069520104
GS1
1
The XVIVO Perfusion System, XPS™, is intended to be used with STEEN Solution™ for flushing and temporary continuous normothermic perfusion of initially unacceptable excised donor lungs, during which time the function of the lungs can be evaluated and assessed as viable transplantable organ.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
Yes
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 An assembly of devices designed to be used for the reconditioning, ex-vivo evaluation and cold preservation of donated lungs prior to transplantation. It typically consists of a mains electricity (AC-powered) unit which includes an operator's console, a roller pump, monitor, heat exchanger unit and gas system. The lungs are placed in a disposable chamber where they are connected, via tubing, to the evaluation unit. Typically, measurements can be made of pulmonary pressure, temperature, and flow, with calculation of pulmonary vascular resistance. The system is intended for use in a hospital in a clean area and is mobile on wheels.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
October 15, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 303 395 9171
info@xvivoperfusion.com
CLOSE