Duns Number:070637129
Device Description: VALVE, ANTI-REFLUX, URINE COLLECTION, SILICONE, HIGH-FLOW, REUSABLE, REPLACEMENTReplacemen VALVE, ANTI-REFLUX, URINE COLLECTION, SILICONE, HIGH-FLOW, REUSABLE, REPLACEMENTReplacement Anti-Reflux Valve for all Urocare Latex Reusable Urine Collection Leg Bags and Drainage Bottles.
Catalog Number
6001
Brand Name
Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)
Version/Model Number
6001
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
-
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
KNX
Product Code Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Public Device Record Key
b41a7b7f-3382-4e75-b985-006361778d52
Public Version Date
May 10, 2021
Public Version Number
5
DI Record Publish Date
April 11, 2018
Package DI Number
10792293060010
Quantity per Package
10
Contains DI Package
00792293060013
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 | 140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |