Duns Number:559895730
Device Description: STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Catalog Number
19004
Brand Name
STEEN Solution™
Version/Model Number
19004
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
84479154-6838-4d0b-809b-8c0f27a78162
Public Version Date
March 29, 2018
Public Version Number
2
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 |