Duns Number:070637129
Device Description: ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENTReplacement Male Uri ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENTReplacement Male Urinal Adapter for all Urocare Male Urinal Systems: #94404, #94403, #94402, #94401, #94400, #94399 and Urinal Kits: #4404, #4403, #4402, #4401, #4400 and #4399.Includes Gasket-Ring #5999 preassembled.
Catalog Number
6022
Brand Name
Urocare® Male Urinal to Latex Leg Bag Adapter
Version/Model Number
6022
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
NNW
Product Code Name
Bag, Urine Collection, Leg, For External Use, Non-Sterile
Public Device Record Key
031ae4f0-151a-46f4-afa5-e672ce03f162
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
10792293060225
Quantity per Package
12
Contains DI Package
00792293060228
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 |