Duns Number:001660786
Device Description: BEQ HMOD 70000Soft Shell Venous Rser 800 mlBlood Transfer Bag 1000 mlBEQ-RF32 RotaflowCDI BEQ HMOD 70000Soft Shell Venous Rser 800 mlBlood Transfer Bag 1000 mlBEQ-RF32 RotaflowCDI Sat Cell 3/8"Blood Microfilter SystPrebypass FilterGas Filter
Catalog Number
701050060
Brand Name
Child ECC Quadrox iD with RF 3/8"
Version/Model Number
BEQ-TOP 21502
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2021
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
2793c35b-6df9-4232-9656-b70540b89a80
Public Version Date
December 16, 2021
Public Version Number
5
DI Record Publish Date
December 28, 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 |