Duns Number:063519193
Device Description: Paramount Medical Solutions Urology Drain Bags Vinyl Fits Hoop Style Urology Frames 50 per Paramount Medical Solutions Urology Drain Bags Vinyl Fits Hoop Style Urology Frames 50 per Case
Catalog Number
-
Brand Name
Paramount Medical Solutions
Version/Model Number
31432
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMZ
Product Code Name
Table, Cystometric, Electric
Public Device Record Key
a678268c-3014-4061-9411-cb12a2e688ea
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
Package DI Number
10618125160973
Quantity per Package
50
Contains DI Package
00618125160976
Package Discontinue Date
-
Package Status
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |