DeRoyal
Rectangular Basin - 8000CC
65manufacturers in China registered for this device type
42catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (19), Zhejiang (16), Shanghai (13). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
Showing 12 of 65. All 65 manufacturers in China registered for Basin, Emesis
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FNY |
| Device type | Basin, Emesis |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6730 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-23 |
| Record revised | 2021-10-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 160, case of 340, case of 8, case of 320, case of 60, case of 3240 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD-395-0700EU | In distribution | |
| HD-395-1000-RDEU | In distribution | |
| HD-395-7000EU | In distribution | |
| HD-395-2500 | In distribution | |
| HD-395-1500-T | In distribution | |
| HD-395-0700 | In distribution | |
| HD-395-1000 | In distribution | |
| HD-395-6000 | In distribution | |
| HD-395-1000-T | In distribution | |
| HD-395-2500EU | In distribution | |
| 607OR-HD-CT | In distribution | |
| HD-395-0500-T | In distribution | |
| HD-395-6000PINK | In distribution | |
| HD-395-1500 | In distribution | |
| 89-5002 | In distribution | |
| HD-395-0500 | In distribution | |
| 89-1605 | In distribution | |
| HD-395-6000-T | In distribution | |
| 610OR-HD-CT | In distribution | |
| 31-027 | In distribution | |
| HD-395-0700CT | In distribution | |
| HD-395-2500REDEU | In distribution | |
| HD-395-1500B | In distribution | |
| HD-395-7000 | In distribution | |
| HD-395-0250 | In distribution | |
| HD-395-0700-T | In distribution | |
| HD-395-0500EU | In distribution | |
| HD-395-6000EU | In distribution | |
| HD-395-8000-T | In distribution | |
| HD-395-2500RED | In distribution | |
| 89-5014 | In distribution | |
| HD-395-1500EU | In distribution | |
| 89-5001 | In distribution | |
| HD-395-7000-T | In distribution | |
| HD-395-0700CTEU | In distribution | |
| HD-395-8000EU | In distribution | |
| HD-395-8000 | In distribution | |
| HD-395-6000CTEU | In distribution | |
| HD-395-1000-RD | In distribution | |
| HD-395-1000CTEU | In distribution | |
| HD-395-1000EU | In distribution | |
| HD-395-1000CT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 51 |
| HNM Medical | HNM Stainless, LLC. | 50 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 38 |
| Novo Health Services, LLC | Novo Health Services, LLC | 35 |
| Medegen Medical Products, LLC | Medegen Medical Products | 27 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 19 |
| CHS | Canadian Hospital Specialties Ltd. | 16 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 15 |
| Gimmi | Gimmi Gmbh | 14 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 13 |
| Curaplex | Bound Tree Medical, LLC | 13 |
| LSL Healthcare | Lsl Industries, Inc. | 11 |
Showing 12 of 77. All products under Basin, Emesis
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2023-05-30 | Class II | Process control | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 40 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.