E-Cath® II Tsui®
E-Cath® II Tsui® SonoPlex® Stim cannula 21G with indwelling catheter 18G x 130mm
1manufacturer
9catalogue 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 | 2025-01-30 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 20 to 65 % RH |
| Packaging | Pack of 10 |
| Sizes | Length 50 to 150 mm; needle gauge 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 351285-40E | Length 130.0 mm | In distribution |
| 301185-40E | Length 50.0 mm | In distribution |
| 361185-40E | Needle Gauge 18.0 G | In distribution |
| 361285-40E | Length 100.0 mm | In distribution |
| 311285-40E | Needle Gauge 18.0 G | In distribution |
| 351185-40E | Needle Gauge 18.0 G | In distribution |
| 311185-40E | Needle Gauge 18.0 G | In distribution |
| 371285-40E | Length 150.0 mm | In distribution |
| 301285-40E | Needle Gauge 18.0 G | In distribution |
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 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| 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.