Duns Number:070637129
Device Description: HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGEA simple and cost effective solu HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGEA simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals.
Catalog Number
6384
Brand Name
Urocare® Leg Bag Holder, Upper Large
Version/Model Number
6384
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
98410a9b-ed88-421b-9344-5f4181b06f2d
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 29, 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 |