Duns Number:001660786
Device Description: BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,CDI Sa BEQ-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800ml,BEQ-RF32 RotaFlow,CDI Sat Cell 1/4" System 100,Blood Microfilter System SQ 40 S,Prebypass filter w/o Vent Porous Media 3/8x3/8,Gas Filter.
Catalog Number
701056549R01
Brand Name
1/4" Specialty Pack
Version/Model Number
BEQ-TOP 39100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2019
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
f5ebd69b-fb55-4209-8dda-c36d4a25f857
Public Version Date
February 22, 2019
Public Version Number
4
DI Record Publish Date
March 09, 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 |