Duns Number:559895730
Device Description: The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated don 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.
Catalog Number
19020
Brand Name
XVIVO Organ Chamber™
Version/Model Number
19020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
PHO
Product Code Name
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Public Device Record Key
0fd695a2-d991-4b00-97c0-96c317c35631
Public Version Date
December 22, 2021
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 |