Epinaut
16 catalogue numbers from C60011320, listed by Imedicom Co., Ltd., South Korea, under Catheter, Conduction, Anesthetic. 1 manufacturer in China is registered for this product code.
1manufacturer
16catalogue numbers in this listing
2510(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 | Imedicom Co., Ltd., South Korea |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K173541 |
| Record published | 2018-09-21 |
| Record revised | 2019-02-07 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C60011320 | In distribution | |
| C31011320 | In distribution | |
| L33011315 | In distribution | |
| L60011320 | In distribution | |
| L60013820 | In distribution | |
| L60011315 | In distribution | |
| C60011315 | In distribution | |
| L33013820 | In distribution | |
| C31013820 | In distribution | |
| C60013815 | In distribution | |
| C60013820 | In distribution | |
| C31011315 | In distribution | |
| L33013815 | In distribution | |
| L33011320 | In distribution | |
| C31013815 | In distribution | |
| L60013815 | 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 |
| 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 |
|---|---|
| K173541 | 2018-08-24 |
| K150789 | 2016-03-01 |
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.