Mediplus
Silicone 2 way Foley (open tip) catheter , 12Fr, standard
1manufacturer
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Mediplus Ltd., United Kingdom |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132890 |
| Record published | 2015-10-17 |
| Record revised | 2020-12-04 (version 9) |
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 |
| Packaging | Carton of 10 |
| Sizes | Length 42 cm; catheter gauge 12 to 16 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5765 | Length 42.0 cm | In distribution |
| 5767 | Length 42.0 cm | In distribution |
| 5764 | Length 42.0 cm | In distribution |
| 5762 | Length 42.0 cm | In distribution |
| 5769 | Length 42.0 cm | In distribution |
| 5766 | Length 42.0 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniSPC Button | Applied Medical Technology, Inc. | 284 |
| Malecot | Cook Incorporated | 39 |
| Cook | Cook Incorporated | 35 |
| Stamey | Cook Incorporated | 16 |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | Fortune Medical Instrument Corp. | 10 |
| Rutner | Cook Incorporated | 9 |
| Silicone Supra-Pubic Catheter (Integrated Balloon) | Fortune Medical Instrument Corp. | 8 |
| Cook-Cope Loop | Cook Incorporated | 8 |
| Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) | Fortune Medical Instrument Corp. | 7 |
| S-Cath™ | Mediplus Ltd. | 7 |
| Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) | Fortune Medical Instrument Corp. | 7 |
| AMT MiniSPC Drainage Set | Applied Medical Technology, Inc. | 6 |
Showing 12 of 23. All products under Catheter, Suprapubic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132890 | 2014-01-17 |
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.