Duns Number:787855907
Device Description: ULPA/Carbon Smoke Evacuation Filter Replacement
Catalog Number
w/Gasket
Brand Name
Buffalo Filter
Version/Model Number
BSUCF03V
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
-
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
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
6561deac-4409-4a56-bdc6-d241c38c40d2
Public Version Date
April 22, 2022
Public Version Number
5
DI Record Publish Date
January 13, 2017
Package DI Number
10851136002997
Quantity per Package
3
Contains DI Package
00851136002990
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 |