OneCath
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.
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Compactcath, Inc, United States |
|---|---|
| FDA product code | EZC |
| Device type | Catheter, Coude |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2018-09-12 |
| Record revised | 2019-01-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 16 in; catheter gauge 10 to 16 Fr |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 202-1610 | Length 16 in | 25 | In distribution |
| 202-1614 | Length 16 in | 25 | In distribution |
| 202-1612 | Length 16 in | 25 | In distribution |
| 202-1616 | Catheter Gauge 16 Fr | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 26 |
| SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray | C.R. Bard, Inc. | 18 |
| Rusch | Teleflex Medical LLC | 14 |
| SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 12 |
| Bard® Urine Meter Foley Tray with Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 11 |
| Bardex® Silicone Coated Foley Catheter | C.R. Bard, Inc. | 10 |
| Bardia | C.R. Bard, Inc. | 10 |
| Bardia® Foley Catheter Silicone Coated | C.R. Bard, Inc. | 10 |
| Bard® Foley Catheter Silicone Coated | C.R. Bard, Inc. | 10 |
| Bard® Lubricath® Foley Catheter | C.R. Bard, Inc. | 10 |
| Bardex® Silicone Elastomer-Coated Foley Catheter Kit | C.R. Bard, Inc. | 8 |
| Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit | C.R. Bard, Inc. | 8 |
Showing 12 of 66. All products under Catheter, Coude
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.