Duns Number:070637129
Device Description: STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLEFor use with most vinyl disposable STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLEFor use with most vinyl disposable or latex reusable leg bags. They are an economical alternative to the standard latex rubber straps packaged with most urine collection bags. An elastic/cotton & body construction allows the self-gripping fastener to attach itself along the length of the strap making it fully adjustable to individual requirements providing a safe, secure hold with a comfortable fit. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed.Set Contains:2 Universal Leg straps and Illustrated Use and Care Instructions.* STRAPS NOT SOLD SEPARATELY** BAGS MUST HAVE STRAP LOOPS/EYELETS FOR STRAPS TO PASS THROUGH
Catalog Number
6390
Brand Name
Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2)
Version/Model Number
6390
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
7ca2fb52-e61f-4e4c-8f60-d1604373a740
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
10792293063905
Quantity per Package
12
Contains DI Package
00792293063908
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 |