Duns Number:316153865
Device Description: Venous Hardshell Cardiotomy Reservoir, Adult: VHK 71000#Venöses Reservoir VHK 71000, vacuu Venous Hardshell Cardiotomy Reservoir, Adult: VHK 71000#Venöses Reservoir VHK 71000, vacuum-tight.
Catalog Number
70106.2605
Brand Name
NA
Version/Model Number
Adult Venous Hardshell Reservoir 71000
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
45e839e1-4bf4-4789-ad70-882cf22f6559
Public Version Date
November 20, 2020
Public Version Number
5
DI Record Publish Date
October 24, 2015
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 |