Rusch
Rusch Intermittent Urethral Catheters are tubular-shaft catheters with an attached funnel connector. The filing identifies the shaft material as PVC and gives a size range from 10 to 24…
Rusch Intermittent Urethral Catheters are tubular-shaft catheters with an attached funnel connector. The filing identifies the shaft material as PVC and gives a size range from 10 to 24 Charriere.
Their stated use is routine drainage of urine from the bladder. The source says the catheters are not intended or designed for indwelling use.
Listed Item
Bladder catether, Tiemann, 2 eyes
Design
The subject summary describes an uncoated catheter shaft and attached funnel. This description is limited to the intermittent catheter device named in the filing.
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | EZC |
| Device type | Catheter, Coude |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K222279 |
| Record published | 2026-05-15 |
| Record revised | 2023-03-06 (version 4) |
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, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Keep away from sunlight |
| Packaging | Box of 50, ct of 12, carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 221800-000140 | In distribution | |
| IPN050977 | In distribution | |
| IPN050974 | In distribution | |
| IPN050971 | In distribution | |
| IPN050973 | In distribution | |
| IPN050975 | In distribution | |
| 221800-000220 | In distribution | |
| 221800-000240 | In distribution | |
| 221800-000180 | In distribution | |
| 221800-000200 | In distribution | |
| 221800-000160 | In distribution | |
| IPN050976 | In distribution | |
| 221800-000120 | In distribution | |
| IPN050972 | 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 |
| 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 |
| Bard® Foley Tray with Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 8 |
Showing 12 of 66. All products under Catheter, Coude
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222279 | 2022-08-29 |
| K173596 | 2018-01-29 |
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.