Duns Number:001660786
Device Description: BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBlood Transfer Bag 1000 ml BEQ-HMOD 70000-USA Adult Quadrox iDSoftshell Venous Reser. 800mlBlood Transfer Bag 1000 ml - 2 spike portsBEQ-RF32 RotaFlowBlood Microfilter System SQ 40 SPrebypass filter w/o Vent Porous Media 3/8x3/8Gas Filter
Catalog Number
701050228
Brand Name
3/8 QiD pack w/Better Bladder
Version/Model Number
BEQ-TOP 5900
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 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
10c060fb-2d4d-4dd9-a81f-e53742fc38c6
Public Version Date
December 02, 2019
Public Version Number
5
DI Record Publish Date
February 20, 2016
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 |