Duns Number:070637129
Device Description: BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Hooks for Hanging #4102, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999.
Catalog Number
4100
Brand Name
Urocare® Reusable Urinary Drainage Bottle 2,000 mL.
Version/Model Number
4100
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
KNX
Product Code Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Public Device Record Key
a0cf87a2-8792-4c25-87f5-45df3b7a3638
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
April 11, 2018
Package DI Number
10792293041002
Quantity per Package
12
Contains DI Package
00792293041005
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 |