Duns Number:001660786
Device Description: HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, SAT/CRIT conn 1/2", Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter.
Catalog Number
701067370R02
Brand Name
Open Heart Pack w/o Plegiox
Version/Model Number
BO-TOP 38803
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 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
83619499-65e6-4fa8-98f3-a72e83c98a73
Public Version Date
January 28, 2019
Public Version Number
5
DI Record Publish Date
October 05, 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 |