Duns Number:316153865
Device Description: QUADROX-i Adult Microporous Membrane Oxygenator with integrated arterial filter, BIOLINE c QUADROX-i Adult Microporous Membrane Oxygenator with integrated arterial filter, BIOLINE coated, with a screw connector
Catalog Number
70106.7829
Brand Name
QUADROX-i
Version/Model Number
BEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +Filter
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150267,K150267
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
3240980a-5d3d-40a2-a375-f231b16e0ccd
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
February 16, 2017
Package DI Number
04058863017389
Quantity per Package
4
Contains DI Package
04058863017372
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |