Duns Number:070637129
Device Description: BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else?Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defect through each phase of manufacturing and packaged individually in a sterile, easy, peel-open pouch with two(2) “latex-free” leg straps.Features/Contains:Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Front with White Back for easy monitoring for blood or other substances in urine, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions.
Catalog Number
77181
Brand Name
Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)
Version/Model Number
77181
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
932d1653-0d68-4959-984a-a6ca910711ef
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
April 10, 2018
Package DI Number
20792293771814
Quantity per Package
168
Contains DI Package
00792293771810
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 |