Duns Number:001660786
Device Description: BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, CDI Sat Cell 1/4" System 100, Pall LG6 Arterial filter, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Temperature Probe.
Catalog Number
701052174R01
Brand Name
ECC Pack w-HMOD 30000
Version/Model Number
BO-TOP 22702
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 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
f500e514-e446-4d2b-bc8f-f690db1b3bfc
Public Version Date
January 28, 2019
Public Version Number
5
DI Record Publish Date
October 04, 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 |