Duns Number:316153865
Device Description: Venous Hardshell Cardiotomy Reservoir, Adult, non-coated, with cardiotomy filter, without Venous Hardshell Cardiotomy Reservoir, Adult, non-coated, with cardiotomy filter, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Catalog Number
70106.2604
Brand Name
VHK reservoir Ad
Version/Model Number
VHK 70000, Venous Reservoir
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 12, 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
K132166
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
89feef67-17ee-43d7-b64a-ec30697c8688
Public Version Date
November 20, 2020
Public Version Number
5
DI Record Publish Date
March 13, 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 |