UniTip Catheter
- Primary DI
- 07640172972113
- Brand
- UniTip Catheter
- Company
- Unisensor AG
- Model
- K8104-00-9409-D
- Published
- 2016-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
unisensor.chProduct Codes
| Code | Name |
|---|---|
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07640172972113 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07640172972113 | 07640172972113 | 7640172972113 |
GMDN Terms
| Term | Definition |
|---|---|
| Urodynamic manometric catheter, electronic, reusable | A non-sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may in addition have impedance electrodes and/or a lumen to fill/drain the bladder to facilitate pressure measurement. This is a reusable device intended to be sterilized/cleaned prior to use. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 8 | French |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(603)570-2675 | qm@unisensor.ch |
Regulatory Flags
- DUNS number
- 483298907
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07640172974025 | UniTip High Resolution Catheter | K1036A2-E-2208 | 2022-11-03 | |
| 07640172974032 | UniTip High Resolution Catheter | K121159-00-2209-D | 2022-11-03 | |
| 07640172974018 | UniTip High Resolution Catheter | K102059-EL-2106-D | 2022-04-20 | |
| 07640172973936 | UniTip High Resolution Catheter | K143659-L6-2103-D | K143659-L6-2103-D | 2022-01-19 |
| 07640172973998 | UniTip High Resolution Catheter | K81759-E-2017-D | K81759-E-2017-D | 2022-01-13 |
| 07640172974001 | UniTip High Resolution Catheter | K8159-00-2101-D | K8159-00-2101-D | 2021-10-20 |
| 07640172973912 | UniTip Catheter | K6604-00-2011-D | 2021-02-18 | |
| 07640172973882 | UniTip High Resolution Catheter | K126A2-00-2014 | 2021-02-04 | |
| 07640172973899 | UniTip High Resolution Catheter | K146A2-00-2015 | 2021-02-04 | |
| 07640172973905 | UniTip High Resolution Catheter | K1212A2-00-2016 | 2021-02-04 | |
| 07640172973851 | UniTip High Resolution Catheter | K1412A2-00-2008 | 2020-12-07 | |
| 07640172973868 | UniTip Catheter | K14172-00-2010 | 2020-12-07 | |
| 07640172973875 | UniTip Catheter | K12172-00-2009 | 2020-12-07 | |
| 07640172973844 | UniTip Catheter | K104A2-00-2006 | 2020-10-27 | |
| 07640172973837 | UniTip High Resolution Catheter | K121459-L5-1912-D | 2020-10-09 | |
| 07640172973813 | UniTip High Resolution Catheter | K1020A1-EL-1911-D | 2019-11-11 | |
| 07640172973783 | UniTip Catheter | K14172-00-1906 | 2019-06-17 | |
| 07640172973790 | UniTip Catheter | K12172-00-1907 | 2019-06-17 | |
| 07640172973806 | UniTip High Resolution Catheter | K143659-00-1910-D | 2019-06-17 | |
| 07640172973769 | UniTip Catheter | K8404-00-1903-D | 2019-05-09 |
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