Duns Number:559895730
Device Description: The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transp The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.
Catalog Number
19005
Brand Name
Silicon Tubing Set
Version/Model Number
19005
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
NEP
Product Code Name
System/Device, Pharmacy Compounding
Public Device Record Key
912951be-b34b-4086-a22e-44db883106c4
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
November 11, 2016
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 |