Duns Number:001660786
Device Description: BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,Better Bladder 1/4,C BEQ-HMOD 30000-USA Pediatric Quadrox iD,Softshell Venous Reser. 800ml,Better Bladder 1/4,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,Pediatric Temp Probe
Catalog Number
709000510
Brand Name
Custom Pack Neonates ECC + QPiD
Version/Model Number
BO-TOP 41202
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 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
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
96949ba6-de2e-412c-ade8-f0fbe89bd47a
Public Version Date
June 12, 2019
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 |