Duns Number:787855907
Device Description: ULPA/Carbon Smoke Evacuation Pre-Filter Replacement
Catalog Number
-
Brand Name
Buffalo Filter
Version/Model Number
BFE3630
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
0dfb5522-0511-442a-9283-cd915254dd9a
Public Version Date
April 22, 2022
Public Version Number
5
DI Record Publish Date
January 13, 2017
Package DI Number
10851136002737
Quantity per Package
5
Contains DI Package
00851136002730
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
pouch
| 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 |