BD Luer-Lok, BD Glaspak
Tray SPN WHIT25G3.5 L/B-D/E W Shrp Stic
1manufacturer
36catalogue 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 | 2025-08-11 (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 |
| Packaging | Case of 10 |
| Distribution end date | 2023-02-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 405733 | 10 | In distribution | |
| 405730 | 10 | In distribution | |
| 405673 | 10 | In distribution | |
| 405637 | 10 | In distribution | |
| 405638 | 10 | In distribution | |
| 405741 | 10 | In distribution | |
| 405674 | 10 | In distribution | |
| 405699 | 10 | In distribution | |
| 405718 | 10 | In distribution | |
| 405609 | 10 | In distribution | |
| 405646 | 10 | In distribution | |
| 405639 | 10 | In distribution | |
| 405652 | 10 | In distribution | |
| 405651 | 10 | In distribution | |
| 405709 | 10 | In distribution | |
| 405736 | 10 | In distribution | |
| 405672 | 10 | In distribution | |
| 405671 | 10 | In distribution | |
| 405735 | 10 | In distribution | |
| 405707 | 10 | In distribution | |
| 405644 | 10 | In distribution | |
| 405645 | 10 | In distribution | |
| 405621 | 10 | In distribution | |
| 405715 | Withdrawn | ||
| 405636 | Withdrawn | ||
| 405704 | Withdrawn | ||
| 405623 | Withdrawn | ||
| 405678 | Withdrawn | ||
| 405684 | Withdrawn | ||
| 405685 | Withdrawn | ||
| 405624 | Withdrawn | ||
| 405706 | Withdrawn | ||
| 405611 | Withdrawn | ||
| 405724 | Withdrawn | ||
| 405682 | Withdrawn | ||
| 405622 | Withdrawn |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 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| 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 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 990 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 3,130 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 330 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 3,550 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 290 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 13,320 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 0 units |
| Becton, Dickinson & Co. | UDI-DI | 2026-04-27 | Class I | Nonconforming Material/Component | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing s | 5,940 units |
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.