Duns Number:070637129
Device Description: GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10Replacement G GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10Replacement Gasket-Ring for: Urinary Drainage Bottle 2,000 mL. #4100, Urinary Drainage Bottle 4,000 mL. #4140 and Anti-Reflux Valve #6001 found in all Urocare Latex Urinary Leg Bags.
Catalog Number
6000
Brand Name
Urocare® Gasket Ring, Large (Set of 10)
Version/Model Number
6000
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"
-
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
c1e2e3b0-70c0-4e95-8423-63236751079f
Public Version Date
May 10, 2021
Public Version Number
5
DI Record Publish Date
April 11, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |