Mediplus
Pump tube set for urodynamics system - Mediwatch/Medtronic/Dantec
3manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Mediplus Ltd., United Kingdom |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2024-08-07 (version 3) |
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 | Pack of 25, pack of 50, pack of 10, pack of 20, pack of 40 |
| Sizes | Length 5 to 200 cm; lumen/inner diameter 1.5 to 3.5 mm; length 0.6 to 4.6 m; catheter gauge 6 to 9 Fr; outer diameter 3.1 mm; width 38 to 48 mm |
| Distribution end date | 2024-08-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9115 | Outer Diameter 3.1 mm | In distribution |
| 9015 | Lumen/Inner Diameter 1.5 mm | In distribution |
| 5182 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 5331 | Length 50.0 cm | In distribution |
| 5704Y | Length 65.0 cm | In distribution |
| 5332 | Catheter Gauge 9.0 Fr | In distribution |
| 5704 | Length 65.0 cm | In distribution |
| 5180 | In distribution | |
| 5807 | Length 3.9 m | In distribution |
| 5335 | Catheter Gauge 9.0 Fr | In distribution |
| 9200 | Length 200.0 cm | In distribution |
| 5724Y | Catheter Gauge 6.0 Fr | In distribution |
| 3651 | Width 38.0 mm | In distribution |
| 5833 | Length 1.5 m | In distribution |
| 9150 | Outer Diameter 3.1 mm | In distribution |
| 9025 | Outer Diameter 3.1 mm | In distribution |
| 5706 | Catheter Gauge 8.0 Fr | In distribution |
| 5183 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 9111 | Length 100.0 cm | In distribution |
| 3650 | Width 48.0 mm | In distribution |
| 9100 | Length 100.0 cm | In distribution |
| 9050 | Outer Diameter 3.1 mm | In distribution |
| 5300 | Catheter Gauge 8.0 Fr | In distribution |
| 5900 | Length 60.0 cm | Withdrawn |
| 5620 | Withdrawn | |
| 5801/1 | Length 3.75 m | Withdrawn |
| 5625 | Withdrawn | |
| 5901 | Catheter Gauge 6.0 Fr | Withdrawn |
| 9003 | Lumen/Inner Diameter 1.5 mm | Withdrawn |
| 5806 | Length 3.75 m | Withdrawn |
| 5850 | Withdrawn | |
| 5626 | Withdrawn | |
| 5001 | Length 2.9 m | Withdrawn |
| 5822 | Length 2.95 m | Withdrawn |
| 5333 | Length 40.0 cm | Withdrawn |
| 5851 | Withdrawn | |
| 5832 | Length 3.95 m | Withdrawn |
| 5820 | Length 2.95 m | Withdrawn |
| 5872 | Length 3.4 m | Withdrawn |
| 91255 | Lumen/Inner Diameter 1.5 mm | Withdrawn |
| 5840 | Length 3.4 m | Withdrawn |
| 993 | Length 4.6 m | Withdrawn |
| 5812 | Length 0.6 m | Withdrawn |
| 91250 | Outer Diameter 3.1 mm | Withdrawn |
| 5603 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Air-Charged Reusable Cable | Laborie Medical Technologies, Canada ULC | 63 |
| UniTip Catheter | Unisensor AG | 45 |
| Atmos Air-Charged Pressure Sensor | Medkonsult Medical Technology S.R.O. | 24 |
| Porges Coloplast | Coloplast A/S | 13 |
| Abviser | Convatec, Purchasing Department | 9 |
| NXT | Laborie Medical Technologies Corp. | 7 |
| Pump Tube Set | Laborie Medical Technologies, Canada ULC | 7 |
| Cystometry Pack | Laborie Medical Technologies, Canada ULC | 7 |
| Lumax TS Pro | Coopersurgical, Inc. | 6 |
| Bard® Urodynamic Catheter, Triple Lumen | C.R. Bard, Inc. | 6 |
| e∙Sense | Pendracare International B.V. | 5 |
| Timm | Mediplus Ltd. | 4 |
Showing 12 of 238. All products under Device, Cystometric, Hydraulic
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.