Duns Number:054765780
Device Description: The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine The OneCath-Hydro Hydrophilic 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
2031-0812
Brand Name
OneCath Hydro
Version/Model Number
2031-0812
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
GBM
Product Code Name
Catheter, Urethral
Public Device Record Key
81b03407-ac07-4891-acbb-95f1e1b64c13
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 23, 2021
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 |