Duns Number:070637129
Device Description: BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve.
Catalog Number
4200
Brand Name
Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)
Version/Model Number
4200
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
Yes
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
FAQ
Product Code Name
Bag, Urine Collection, Leg, For External Use, Sterile
Public Device Record Key
1d12be05-5dfa-4700-aefa-38f751ab8fb2
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
April 10, 2018
Package DI Number
10792293042009
Quantity per Package
20
Contains DI Package
00792293042002
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 |