Duns Number:806687406
Device Description: 12V power supply component for the Nautilus(tm) Smart ECMO Module
Catalog Number
48150
Brand Name
MC3 Nautilus(tm) Smart Power Supply 12VDC
Version/Model Number
48150
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
-
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
K191935
Product Code
BYS
Product Code Name
Oxygenator, Long Term Support Greater Than 6 Hours
Public Device Record Key
cf8b3388-ac86-49b8-8b61-bcb3c5ca065f
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |