Busse Hospital Disposables
Central Line Dressing Change Tray w/ Chloraprep
12manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hubei (2), Fujian (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | Anji | Zhejiang | Repacker / relabeller | 13 |
| Shandong Succare Medical Co., Ltd. | Zibo | Shandong | Manufacturer | 12 |
| Ayida (Xiamen) P&C Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Robert Busse & Co., Inc., United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2026-06-09 (version 4) |
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 | Pack of 20, pack of 50, pack of 30, pack of 10, pack of 25 |
| Distribution end date | 2026-06-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 837 | In distribution | |
| 834 | In distribution | |
| 1235 | In distribution | |
| 9153 | In distribution | |
| 4338 | In distribution | |
| 2815 | In distribution | |
| 836 | In distribution | |
| 832 | In distribution | |
| 2085R1 | In distribution | |
| 6256R1 | In distribution | |
| 8078 | In distribution | |
| 1218 | In distribution | |
| 1155R5 | In distribution | |
| 1657 | In distribution | |
| 1958 | In distribution | |
| 4479 | In distribution | |
| 835 | In distribution | |
| 759 | In distribution | |
| 1443 | In distribution | |
| 3432 | In distribution | |
| 5114 | In distribution | |
| 8079 | In distribution | |
| 2491 | Withdrawn | |
| 5677 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,221 |
| Medline | Medline Industries, Inc. | 184 |
| Stradis Medical, LLC. | Stradis Healthcare | 116 |
| Centurion | Centurion Medical Products Corporation | 24 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 15 |
| Wound CareKit | Mirodx, LLC | 12 |
| LSL Healthcare | Lsl Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
Showing 12 of 25. All products under Wound Dressing 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 | 2023-11-30 | Class I | Nonconforming Material/Component | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to p | 536 | |
| 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 |
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.