Duns Number:070637129
Device Description: TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, CONNECTOR, REUSABLEFeatures “Reverse-Grip” TUBING, URINE COLLECTION, OSTOMY, CLEAR-VINYL, CONNECTOR, REUSABLEFeatures “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.Includes #6010 Large Tubing Connector preassembled.
Catalog Number
6019
Brand Name
Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18"
Version/Model Number
6019
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
83cdf634-82ea-4a92-8620-fa4f6a11b482
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
May 31, 2018
Package DI Number
10792293060195
Quantity per Package
12
Contains DI Package
00792293060198
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 |