BD Perisafe, BD Epilor, BD Luer-Lok
Tray Epid Cont WE17G3.5C19FXD P Drap 7ML
1manufacturer
44catalogue numbers in this listing
1510(k) clearance
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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2025-12-11 (version 6) |
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 |
| Storage | Storage environment temperature 20 to 25 °C; Special storage condition: Do not freeze |
| Packaging | Case of 10 |
| Distribution end date | 2020-09-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 406037 | 10 | In distribution | |
| 405804 | 10 | In distribution | |
| 406047 | 10 | In distribution | |
| 406070 | 10 | In distribution | |
| 406073 | 10 | In distribution | |
| 405906 | 10 | In distribution | |
| 406140 | In distribution | ||
| 406097 | In distribution | ||
| 406049 | 10 | In distribution | |
| 406122 | 10 | In distribution | |
| 406098 | 10 | In distribution | |
| 406050 | 10 | In distribution | |
| 406072 | 10 | In distribution | |
| 405812 | 10 | In distribution | |
| 406035 | 10 | In distribution | |
| 406015 | 10 | In distribution | |
| 406092 | 10 | In distribution | |
| 406310 | In distribution | ||
| 406041 | 10 | In distribution | |
| 406060 | 10 | In distribution | |
| 406069 | 10 | In distribution | |
| 406091 | 10 | In distribution | |
| 405828 | 10 | In distribution | |
| 406087 | 10 | In distribution | |
| 405823 | 10 | In distribution | |
| 406157 | 10 | In distribution | |
| 406123 | 10 | In distribution | |
| 405821 | In distribution | ||
| 406046 | In distribution | ||
| 406048 | 10 | In distribution | |
| 406013 | 10 | In distribution | |
| 406034 | 10 | In distribution | |
| 406151 | 10 | In distribution | |
| 406044 | 10 | In distribution | |
| 406082 | 10 | In distribution | |
| 406137 | 10 | In distribution | |
| 406096 | 10 | In distribution | |
| 406090 | Withdrawn | ||
| 406154 | Withdrawn | ||
| 406040 | Withdrawn | ||
| 406156 | Withdrawn | ||
| 406036 | Withdrawn | ||
| 406079 | Withdrawn | ||
| 406081 | 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 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| 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 |
|---|---|
| K210983 | 2022-05-19 |
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.