Duns Number:787855907
Device Description: In-Line Smoke Evacuation Filter/Multi-Use ULPA
Catalog Number
-
Brand Name
Buffalo Filter
Version/Model Number
BILF200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
230a507d-f632-4585-b09f-ba32329c387b
Public Version Date
April 22, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
10851136002324
Quantity per Package
10
Contains DI Package
00851136002327
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |