Duns Number:070637129
Device Description: STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, VELCRO FASTENERS, REUSABLEThere is an easier w STRAP, FABRIC, FOLEY, CATHETER, LATEX-FREE, VELCRO FASTENERS, REUSABLEThere is an easier way to keep things in their place... Find out how easy it can be to attach your Foley® catheter or tubing with this elastic fabric strap. It's unique design distributes pressure evenly along the length of the strap offering a vast improvement in comfort while reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and/or burns. The self-gripping fastener can engage anywhere along the length of the strap body making the strap fully adjustable to individual requirements. The durable material is hand or machine washable and the strap is available in multiple sizesContains:1 Fabric Catheter Strap,Use and Care Instructions
Catalog Number
6312
Brand Name
Urocare® Fabric Foley® Catheter/Tubing Strap Large 22"
Version/Model Number
6312
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
KNX
Product Code Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Public Device Record Key
d87dceb1-a949-43ed-80af-c6a6d58f38c5
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
May 30, 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 |