E-Cath Plus Acc. Tsui
E-Cath Plus acc. Tsui SonoPlex Stim cannula 20G x 150mm indwelling catheter 16G x 132mm
1manufacturer
17catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K152952 |
| Record published | 2016-10-14 |
| Record revised | 2019-12-31 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 201285-41E | 10 | Withdrawn | |
| 251185-41E | 10 | Withdrawn | |
| 241285-41E | 10 | Withdrawn | |
| 201185-41E | 10 | Withdrawn | |
| 241185-41E | 10 | Withdrawn | |
| 241285-41E | 10 | Withdrawn | |
| 271285-41E | 10 | Withdrawn | |
| 251185-41E | 10 | Withdrawn | |
| 241185-41E | 10 | Withdrawn | |
| 261285-41E | 10 | Withdrawn | |
| 201285-41E | 10 | Withdrawn | |
| 251285-41E | 10 | Withdrawn | |
| 251285-41E | 10 | Withdrawn | |
| 211185-41E | 10 | Withdrawn | |
| 211185-41E | 10 | Withdrawn | |
| 201185-41E | 10 | Withdrawn | |
| 211285-41E | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
| E-Cath® NRFit Tsui® | Pajunk Gmbh Medizintechnologie | 6 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172777 | 2018-05-03 |
| K152952 | 2016-07-13 |
| K080675 | 2008-06-20 |
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.