Duns Number:070637129
Device Description: GASKET RING, VALVE, URINE COLLECTION, SMALL, REUSABLE, REPLACEMENT, SET OF 10Replacement G GASKET RING, VALVE, URINE COLLECTION, SMALL, REUSABLE, REPLACEMENT, SET OF 10Replacement Gasket-Ring for: Bottom Drain Valve #6004, Straight-Thru Adapter with Thumb Clamp #6005, Male Urinal to Latex Leg Bag Adapter #6022, Quick Drain Valve Standard #700110, Quick Drain Valve Medium #700118 and Quick Drain Valve Large #700172.
Catalog Number
5999
Brand Name
Urocare® Gasket Ring, Small (Set of 10)
Version/Model Number
5999
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
fbb6cad1-a8d8-4b8a-976e-042cc2829c02
Public Version Date
July 06, 2018
Public Version Number
3
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 |