Duns Number:001660786
Device Description: BO-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800m,Blood Transfer Bag 1000 ml BO-HMOD 70000-USA Adult Quadrox iD,Softshell Venous Reser. 800m,Blood Transfer Bag 1000 ml - 2 spike ports,Better Bladder 3/8,Blood Microfilter System SQ 40 S,Prebypass filter w/o Vent Porous Media 3/8x3/8,Gas Filter
Catalog Number
701052176
Brand Name
ECC 3/8"
Version/Model Number
BO-TOP 22701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 20, 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)
-
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
d2836650-1203-4296-9d77-cfff34cc00f4
Public Version Date
January 28, 2019
Public Version Number
5
DI Record Publish Date
February 14, 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 |