Duns Number:316153865
Device Description: QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy re QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight
Catalog Number
70106.7970
Brand Name
QUADROX-i
Version/Model Number
Small Adult, reservoir, filter VKMO 51000-USA #SQUADR-i HMO51000+VHK710
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
K132166
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
55f58c34-b4fe-4c8b-94b3-7525c752bc5b
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
February 15, 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 |