Duns Number:313013477
Device Description: The Medos hilite 1000 oxygenator is indicated for use in procedures requiring the extracor The Medos hilite 1000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.2 to 1.0 liters per minute.
Catalog Number
MW 6208 0001
Brand Name
hilite
Version/Model Number
hilite 1000 hollow fiber oxygenator for neonates and infants, model 0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 29, 2020
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
df2ef9f1-2d2b-4c36-9805-2fed99dfde0e
Public Version Date
July 30, 2020
Public Version Number
4
DI Record Publish Date
September 30, 2015
Package DI Number
04250358153262
Quantity per Package
8
Contains DI Package
04250358151640
Package Discontinue Date
July 29, 2020
Package Status
Not in Commercial Distribution
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 |