Cook
Bladder Pressure Catheter
3manufacturers in China registered for this device type
2catalogue 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2020-08-17 (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 |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G15764 | In distribution | |
| G16563 | 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 |
| Lumax TS Pro | Coopersurgical, Inc. | 6 |
| Bard® Urodynamic Catheter, Triple Lumen | C.R. Bard, Inc. | 6 |
| e∙Sense | Pendracare International B.V. | 5 |
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.