Duns Number:054765780
Device Description: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Catalog Number
1612
Brand Name
OneCath
Version/Model Number
201-1612
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZD
Product Code Name
Catheter, Straight
Public Device Record Key
63f7e092-8c60-4199-8d71-efdbe91a51f2
Public Version Date
July 26, 2018
Public Version Number
1
DI Record Publish Date
June 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |