Duns Number:070637129
Device Description: TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE, STERILEFeatures “ TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, NOZZLE ADAPTER, REUSABLE, STERILEFeatures “Reverse-Grip” technology and graduated barbs to provide a secure hold on most standard sized drainage or extension tubing. May be used to connect 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.DEHP-Free and Latex-Free.Nozzle adapter and cap are preassembled.
Catalog Number
6085
Brand Name
Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5"
Version/Model Number
6085
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
6e9cd848-51a7-4f1f-9195-f9817ef24ff9
Public Version Date
May 10, 2021
Public Version Number
7
DI Record Publish Date
May 31, 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 |