Duns Number:071595540
Device Description: PowerPro SureCharge Disposable Filter Pack, 50/pk
Catalog Number
PRO3205
Brand Name
POWERPRO
Version/Model Number
PRO3205
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 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
K012320,K012320,K012320
Product Code
HAB
Product Code Name
SAW, POWERED, AND ACCESSORIES
Public Device Record Key
76c18d30-d3a7-42cf-9661-72bb7ed4debb
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 29, 2020
Package DI Number
20845854036096
Quantity per Package
50
Contains DI Package
10845854053041
Package Discontinue Date
June 09, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |