Duns Number:001660786
Device Description: BEQ-HMO 71000BO-VHK 71000BEQ-RF 32 RotaFlowBC 140 PlusCdi Sat cell 1/2"Cardiooplegia Filte BEQ-HMO 71000BO-VHK 71000BEQ-RF 32 RotaFlowBC 140 PlusCdi Sat cell 1/2"Cardiooplegia FilterPrebypass filterGas Filter
Catalog Number
701063071
Brand Name
Custom CPB Pack w/ VKMO 71000
Version/Model Number
BEQ-TOP 30901
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)
Yes
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
-
Product Code
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
57758225-4274-4440-9233-5e5293af61b5
Public Version Date
December 02, 2019
Public Version Number
5
DI Record Publish Date
November 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 663 |