Duns Number:559895730
Device Description: XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect iso XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.
Catalog Number
19023
Brand Name
XVIVO Lung Cannula Set II™
Version/Model Number
19023
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P180014
Product Code
PHO
Product Code Name
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Public Device Record Key
a12fe2eb-fa55-4cec-8153-1877b43ad203
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2021
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 |