Duns Number:316153865
Device Description: QUADROX-iD Adult, without filter, BIOLINE Coating, non-sterile, semi-finished product.
Catalog Number
70105.3325
Brand Name
QUADROX-iD
Version/Model Number
BEQ-01970311
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132829
Product Code
DTR
Product Code Name
HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Public Device Record Key
51fe94cf-665c-4097-8a8a-c310a816c7f2
Public Version Date
February 03, 2020
Public Version Number
6
DI Record Publish Date
November 16, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |