Duns Number:070637129
Device Description: TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER, MALE, EXTERNAL, CATHETER, REUSABLETubing TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER, MALE, EXTERNAL, CATHETER, REUSABLETubing may be easily cut to desired length and used as an extension between Uro-Con® or Uro-Cath® male external catheters, Foley® indwelling catheters and reusable or disposable urinary drainage bags, bottles or other urinary and ostomy appliances. Provides a snug fit on most standard sized drainage ports/outlets while resisting kinks.
Catalog Number
600831
Brand Name
Urocare® Pliable White-Rubber Drainage Tubing, Large 0.31" I.D. x 10 ft.
Version/Model Number
600831
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
FAQ
Product Code Name
Bag, Urine Collection, Leg, For External Use, Sterile
Public Device Record Key
60d79584-b013-4ccb-8e36-2708951ce198
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
May 30, 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 |