Duns Number:009299017
Device Description: VII VIRAL/BACTERIAL FILTER - Distributed by Philips
Catalog Number
342077
Brand Name
VIROBAC II®
Version/Model Number
342077
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K880681,K880681
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
083cd172-7015-4feb-a116-2d084b5b52e5
Public Version Date
April 27, 2022
Public Version Number
1
DI Record Publish Date
April 19, 2022
Package DI Number
00612649215693
Quantity per Package
10
Contains DI Package
00612649215709
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |