Duns Number:001660786
Device Description: VHK 71000 Venous Reservoir - uncoated, BEQ-RF32 RotaFlow,
Catalog Number
701053314
Brand Name
Veno - Veno Pack
Version/Model Number
BEQ-T 28904
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 20, 2018
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"
Yes
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
-
Product Code
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
1091310a-cad0-4c5a-ad70-674a9f421a84
Public Version Date
December 02, 2019
Public Version Number
5
DI Record Publish Date
March 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 663 |