UniTip Catheter
45 catalogue numbers from K6104-00-9407-D, listed by Unisensor AG, United States, under Device, Cystometric, Hydraulic. 3 manufacturers in China are registered for this product code.
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 | Unisensor AG, United States |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2019-01-04 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Catheter gauge 3 to 10 Fr |
| Distribution end date | 2019-01-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K6104-00-9407-D | Catheter Gauge 6 Fr | In distribution |
| K8104-00-0202-D | Catheter Gauge 8 Fr | In distribution |
| K8204-L4-9302-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-9939-D | Catheter Gauge 8 Fr | In distribution |
| K8104-00-9409-D | Catheter Gauge 8 Fr | In distribution |
| K6204-L3-0963-D | Catheter Gauge 6 Fr | In distribution |
| K4100-00-9783-D | Catheter Gauge 4 Fr | In distribution |
| K8204-L4-9706-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-9901-D | Catheter Gauge 8 Fr | In distribution |
| K8204-EL4-9945-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-9301-D | Catheter Gauge 8 Fr | In distribution |
| K8200-EL4-12122-D | Catheter Gauge 8 Fr | In distribution |
| K3104-00-9722-D | Catheter Gauge 3 Fr | In distribution |
| K8226-L4-9304-D | Catheter Gauge 8 Fr | In distribution |
| K8230-L4-9718 | Catheter Gauge 8 Fr | In distribution |
| K6200-L3-0539-D | Catheter Gauge 6 Fr | In distribution |
| K8200-L4-9717-D | Catheter Gauge 8 Fr | In distribution |
| K6133-00-1179 | Catheter Gauge 6 Fr | In distribution |
| K8100-00-9434-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-0032-D | Catheter Gauge 8 Fr | In distribution |
| K5104-00-0049-D | Catheter Gauge 5 Fr | In distribution |
| K8200-L4-0217-D | Catheter Gauge 8 Fr | In distribution |
| K8100-L4-9710-D | Catheter Gauge 8 Fr | In distribution |
| K6204-00-9758-D | Catheter Gauge 6 Fr | In distribution |
| K8204-00-1093-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-0316-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-0209-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-0580-D | Catheter Gauge 8 Fr | In distribution |
| K10204-L5-1045-D | Catheter Gauge 10 Fr | In distribution |
| K8230-L4-9713 | Catheter Gauge 8 Fr | In distribution |
| K8281-L4-0504-D | Catheter Gauge 8 Fr | In distribution |
| K6200-L3-0569-D | Catheter Gauge 6 Fr | In distribution |
| K8200-L4-1565-D | Catheter Gauge 8 Fr | In distribution |
| K8104-L4-1713-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-0031-D | Catheter Gauge 8 Fr | In distribution |
| K6104-L3-0301-D | Catheter Gauge 6 Fr | In distribution |
| K8104-L4-9920-D | Catheter Gauge 8 Fr | In distribution |
| K8204-E-0514-D | Catheter Gauge 8 Fr | In distribution |
| K8100-00-9906-D | Catheter Gauge 8 Fr | In distribution |
| K6200-L3-0086-D | Catheter Gauge 6 Fr | In distribution |
| K8204-EL4-1135-D | Catheter Gauge 8 Fr | In distribution |
| K8200-L4-9721-D | Catheter Gauge 8 Fr | In distribution |
| K6204-L3-0962-D | Catheter Gauge 6 Fr | In distribution |
| K8200-L4-9436-D | Catheter Gauge 8 Fr | Withdrawn |
| K8204-L4-9427-D | Catheter Gauge 8 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Air-Charged Reusable Cable | Laborie Medical Technologies, Canada ULC | 63 |
| Mediplus | Mediplus Ltd. | 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.