Duns Number:809784593
Device Description: UNO_33094182 FilterFlow handle W/O tube
Catalog Number
33094182
Brand Name
FilterFlow
Version/Model Number
33094182
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 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"
-
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
d2597f6a-3297-4da9-89fc-f2f612ea5e33
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
05705243311795
Quantity per Package
20
Contains DI Package
00768455145690
Package Discontinue Date
May 20, 2022
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |