Duns Number:070637129
Device Description: STRAP, LEG BAG, LATEX-FREE, VELCRO, BUTTONS, REUSABLEFits most vinyl disposable urinary le STRAP, LEG BAG, LATEX-FREE, VELCRO, BUTTONS, REUSABLEFits most vinyl disposable urinary leg bags and 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 straps. Large buttons can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fastener 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.Set Contains:1 Upper leg strap #6374,1 Lower leg strap #6375 and Illustrated Use and Care Instructions.* STRAPS NOT SOLD SEPARATELY** BAGS MUST HAVE EYELETS FOR BUTTONS TO PASS THROUGH
Catalog Number
6380
Brand Name
FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2)
Version/Model Number
6380
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
0786f41d-a674-4005-a03b-d290792987cc
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
10792293063806
Quantity per Package
12
Contains DI Package
00792293063809
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 |