Duns Number:070637129
Device Description: URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGEContains: 1 Male Urina URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGEContains: 1 Male Urinal Garment Velcro Closure Universal #4422, 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
4403
Brand Name
Urocare® Male Urinal Kit, Velcro® Closue, Large
Version/Model Number
4403
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
NNX
Product Code Name
Device, Incontinence, Urosheath Type, Non-Sterile
Public Device Record Key
7330ff33-be88-426c-8df4-94892f61fde1
Public Version Date
June 01, 2018
Public Version Number
2
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 |