Busse Hospital Disposables
7 catalogue numbers from 1293, listed by Robert Busse & Co., Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Zibo Qichuang Medical Products Co., Ltd. | Zibo | Shandong | Manufacturer | 27 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Xiamen ANK Hygiene Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 11 |
Record
| Listed by | Robert Busse & Co., Inc., United States |
|---|---|
| FDA product code | LRS |
| Device type | I.V. Start Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Premarket notification | Exempt |
| Record published | 2020-05-21 |
| Record revised | 2026-03-23 (version 3) |
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 |
| Packaging | Pack of 50, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1293 | In distribution | |
| 822 | In distribution | |
| 1590 | In distribution | |
| 8318 | In distribution | |
| 8172 | In distribution | |
| 818 | In distribution | |
| 820 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,066 |
| Centurion | Centurion Medical Products Corporation | 886 |
| Medline Industries, Inc. | Medline Industries, Inc. | 740 |
| Medline | Medline Industries, Inc. | 621 |
| Medical Action Industries | Medical Action Industries, Inc. | 512 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| Motion Medical Distributing | Haslam Medical, Inc. | 118 |
| LSL Healthcare | Lsl Industries, Inc. | 83 |
| Vygon | Vygon Corp. | 76 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 63 |
| MediChoice | Owens & Minor Distribution, Inc. | 46 |
| McKesson | Mckesson Medical-Surgical Inc. | 21 |
Showing 12 of 58. All products under I.V. Start Kit
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 | 2475 | 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 | 4218 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.