Duns Number:331791694
Device Description: The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffusion across a polymethylpentene (PMP) hollow fibre membrane material. Used in conjunction with a heart-lung machine along with a separate venous reservoir and heat exchanger, the sLA Membrane Lung can be used in open-heart surgery.
Catalog Number
8800076
Brand Name
sLA Membrane Lung
Version/Model Number
Novalung® Surgical Lung Assist (sLA) MembraneLung TM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
DTZ
Product Code Name
Oxygenator, Cardiopulmonary Bypass
Public Device Record Key
64b61b85-ba44-40aa-9e82-943f7273e039
Public Version Date
February 13, 2020
Public Version Number
5
DI Record Publish Date
September 30, 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. | 5 |