Duns Number:001660786
Device Description: BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,Blood Transfer Bag 1 BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,Blood Transfer Bag 1000 ml - 2 spike ports,Better Bladder 1/4,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,Temperature Probe
Catalog Number
709000498
Brand Name
BSW /McLANE 1/4 Quadrox iD Pack
Version/Model Number
BEQ-TOP 54501
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 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)
-
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
c9d3728d-da08-43f5-b8e4-43189264461e
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
May 09, 2018
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 |