Duns Number:559895730
Device Description: The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
Catalog Number
19035
Brand Name
XVIVO Lung Disposables Kit
Version/Model Number
19035
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 11, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PHO
Product Code Name
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Public Device Record Key
6238b2fe-82a2-49d4-b178-df08b425bed2
Public Version Date
March 14, 2022
Public Version Number
4
DI Record Publish Date
October 15, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 7 |