Duns Number:070637129
Device Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, EXTRA-LARGEContains: 1 Latex URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, EXTRA-LARGEContains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Extra-Large #4423, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
Catalog Number
94404
Brand Name
Urocare® Male Urinal System, Laced Closue, Extra-Large
Version/Model Number
94404
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)
Yes
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
94e20ef5-d2d7-4e66-b5e2-648a8d83e69c
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 |