Duns Number:070637129
Device Description: ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLEOnly ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLEOnly a limited amount of finger or hand control is required to operate these valves independently. Finger loops or a crossbar may be attached to te lever for individual requirements. Fits Urocare® Reusable Latex Leg Bags and Urocare® Male Urinal Sheaths only. Made with pliable, white-rubber tubing and plastic—no metal parts to corrode. May beused as a replacement for the Standard Bottom Drain Valve (#6004) included with all reusable latex leg bags and Male Urinal Sheaths. An effective crossbar can be made by cutting 2" (5cm) from the bottom of the drain valve tube and pushing one end through the hole in the lever until it is centered, forming a “T” shaped bar.Features:• Lever operated for quick, controlled drainage• Threads are sealed to prevent urine from touching the skin while draining the bag• All working parts are urine free• No metal parts or sharp corners• Tube may be cut to desired lengthIncludes Gasket-Ring #5999 preassembled.
Catalog Number
700118
Brand Name
Urocare® Quick Drain Valve™, Medium 18" (45cm) Tube
Version/Model Number
700118
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
NNW
Product Code Name
Bag, Urine Collection, Leg, For External Use, Non-Sterile
Public Device Record Key
30cf5ba8-4d87-4e9f-be1b-424b0ebf96a2
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
June 01, 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 |