Duns Number:177655466
Catalog Number
-
Brand Name
Capiox® Flexible Venous Reservoir
Version/Model Number
3CXFVR1500X
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070839,K070839
Product Code
DTN
Product Code Name
Reservoir, Blood, Cardiopulmonary Bypass
Public Device Record Key
b0fb2774-1b4c-495f-814a-7f8ab50d6056
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
October 06, 2016
Package DI Number
50699753450191
Quantity per Package
5
Contains DI Package
00699753450196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 Piece Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 174 |