Halyard
ECHOBRIGHT* Insulated Echogenic Regional Block Needle with Injection Set and Stimulating Cable and NRFit™ Connector
1manufacturer
422catalogue numbers in this listing
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 | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K941153 |
| Record published | 2017-12-07 |
| Record revised | 2024-04-15 (version 9) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 20, case of 5, pack of 10, case of 25, case of 100 |
| Distribution end date | 2024-06-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 93251 | In distribution | |
| 98440 | In distribution | |
| 93486 | In distribution | |
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| 40781 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 1,340 |
| Arrow | Teleflex Medical LLC | 508 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Integra® | Integra Pain Management | 181 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Kimberly-Clark Corporation | 510(k) number | 2013-10-24 | Class II | Component design/selection | Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe. | 389,300 units | 2017-08-25 |
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.