Epilong
EpiLong Tuohy needle with metal stylet 19Gx50mm 23G x 50 cm Catheter, closed tip,
1manufacturer
79catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K060311 |
| Record published | 2021-04-02 |
| Record revised | 2025-12-01 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 10 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 10 |
| Distribution end date | 2025-11-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0331152-48 | In distribution | ||
| 0331153-48 | In distribution | ||
| 0331152-49 | In distribution | ||
| 0331252-51 | In distribution | ||
| 0531153-51 | In distribution | ||
| 0131153-50 | In distribution | ||
| 0431157-848 | 10 | Withdrawn | |
| 0331153-51 | 10 | Withdrawn | |
| 0531153-51 | 10 | Withdrawn | |
| 0431157-48 | 10 | Withdrawn | |
| 0431187-51 | 10 | Withdrawn | |
| 0431155-51 | 10 | Withdrawn | |
| 0431157-51 | 10 | Withdrawn | |
| 0131153-50 | 10 | Withdrawn | |
| 0321152-49 | 10 | Withdrawn | |
| 0631187-51 | 10 | Withdrawn | |
| 131166-608 | Withdrawn | ||
| 0431155-51 | 10 | Withdrawn | |
| 0331152-48 | 10 | Withdrawn | |
| 0621187-51 | 10 | Withdrawn | |
| 0131156-51 | 10 | Withdrawn | |
| 0331153-48 | 10 | Withdrawn | |
| 0631152-51 | 10 | Withdrawn | |
| 0631187-51 | 10 | Withdrawn | |
| 0431157-51 | 10 | Withdrawn | |
| 0331153-51 | 10 | Withdrawn | |
| 0321152-51 | 10 | Withdrawn | |
| 0331253-51 | 10 | Withdrawn | |
| 0331253-51 | 10 | Withdrawn | |
| 0311152-51 | 10 | Withdrawn | |
| 0431155-48 | 10 | Withdrawn | |
| 0431157-49 | 10 | Withdrawn | |
| 0311152-49 | 10 | Withdrawn | |
| 0331152-48 | 10 | Withdrawn | |
| 0631152-51 | 10 | Withdrawn | |
| 0331253-48 | 10 | Withdrawn | |
| 0321152-49 | 10 | Withdrawn | |
| 0631153-51 | 10 | Withdrawn | |
| 0331253-48 | 10 | Withdrawn | |
| 0621153-51 | 10 | Withdrawn | |
| 0621152-51 | 10 | Withdrawn | |
| 0321152-51 | 10 | Withdrawn | |
| 0431156-48 | 10 | Withdrawn | |
| 0331152-51 | 10 | Withdrawn | |
| 0331152-49 | 10 | Withdrawn | |
| 0431187-51 | 10 | Withdrawn | |
| 0431157-848 | 10 | Withdrawn | |
| 0531152-51 | 10 | Withdrawn | |
| 0431187-48 | 10 | Withdrawn | |
| 0431156-48 | 10 | Withdrawn | |
| 0631153-49 | 10 | Withdrawn | |
| 0331153-48 | 10 | Withdrawn | |
| 0521152-51 | 10 | Withdrawn | |
| 0421157-48 | 10 | Withdrawn | |
| 0531157-51 | 10 | Withdrawn | |
| 0331152-49 | 10 | Withdrawn | |
| 0431187-48 | 10 | Withdrawn | |
| 0431157-48 | 10 | Withdrawn | |
| 0331252-51 | 10 | Withdrawn | |
| 0321152-51 | 10 | Withdrawn | |
| 0321152-49 | 10 | Withdrawn | |
| 0521152-51 | 10 | Withdrawn | |
| 0331153-48 | 10 | Withdrawn | |
| 0331152-49 | 10 | Withdrawn | |
| 0131153-50 | 10 | Withdrawn | |
| 0531157-51 | 10 | Withdrawn | |
| 0431155-48 | 10 | Withdrawn | |
| 0331053-51 | 10 | Withdrawn | |
| 0621152-51 | 10 | Withdrawn | |
| 0531153-51 | 10 | Withdrawn | |
| 0431157-49 | 10 | Withdrawn | |
| 0331152-51 | 10 | Withdrawn | |
| 0331252-51 | 10 | Withdrawn | |
| 0531153-51 | 10 | Withdrawn | |
| 131166-608 | Withdrawn | ||
| 0331152-48 | 10 | Withdrawn | |
| 0531152-51 | 10 | Withdrawn | |
| 0421157-48 | 10 | Withdrawn | |
| 0631152-51 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 1,340 |
| Arrow | Teleflex Medical LLC | 508 |
| Halyard | Avanos Medical, Inc. | 422 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Integra® | Integra Pain Management | 181 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| BD Luer-Lok, BD Glaspak | Becton, Dickinson AND Company | 36 |
| Contiplex® | B. Braun Medical Inc. | 34 |
| Stimulong Sono | Pajunk Gmbh Medizintechnologie | 27 |
| Clint Pharmaceuticals | ICU Medical, Inc | 26 |
Showing 12 of 109. All products under Anesthesia Conduction Kit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202699 | 2020-12-29 |
| K190345 | 2019-05-16 |
| K113188 | 2012-03-01 |
| K082183 | 2008-10-28 |
| K082164 | 2008-10-27 |
| K062902 | 2007-06-07 |
| K062900 | 2007-01-12 |
| K060311 | 2006-06-13 |
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.