Duns Number:070637129
Device Description: STRAP, FABRIC, UPPER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLEFor use with U STRAP, FABRIC, UPPER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLEFor use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526, #8518 and #8509. Offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the strap loops of the leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed.* BAGS MUST HAVE STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
Catalog Number
6344
Brand Name
Urocare® Upper Fabric Leg Strap with Velcro® Fasteners, Large 12" ~ 21" DIA.
Version/Model Number
6344
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
d45bbd21-7936-40a8-9cde-aeb779e58870
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
10792293063448
Quantity per Package
12
Contains DI Package
00792293063441
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 |