Lumax TS Pro
Lumax TS Pro Fiberoptic Transmission Cable Reusable • Length: 44" (112 cm)
3manufacturers in China registered for this device type
6catalogue 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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K953734 |
| Record published | 2016-05-09 |
| Record revised | 2024-02-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10307-005 | In distribution | |
| 23485 | In distribution | |
| 10307-009 | In distribution | |
| 10307-010 | In distribution | |
| 10310-000 | In distribution | |
| TSBAS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Air-Charged Reusable Cable | Laborie Medical Technologies, Canada ULC | 63 |
| Mediplus | Mediplus Ltd. | 45 |
| 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 |
| 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.