Busse Hospital Disposables
10ml Plastic Loss of Resistance (LOR) Syringe with luer lock tip
1manufacturer
215catalogue 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 | Robert Busse & Co., Inc., United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| 510(k) | K063018 |
| Record published | 2016-09-13 |
| Record revised | 2026-04-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Pack of 10, pack of 20, pack of 5, pack of 4, pack of 25, pack of 100 |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3611 | In distribution | |
| 6194R1 | In distribution | |
| 7358 | In distribution | |
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| 7915 | Withdrawn | |
| 3272 | Withdrawn | |
| 3569 | Withdrawn | |
| 2401R2 | Withdrawn | |
| 3619 | Withdrawn | |
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| 1993R3 | Withdrawn | |
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| 2400R2 | Withdrawn | |
| 1667 | Withdrawn |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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061737 | 2006-12-18 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 200 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 60 units | 2024-04-17 |
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.