Onset
Mixing Pen
68manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (13), Shanghai (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. | Longgang Dist, Shenzhen | Guangdong | Contract manufacturer | 15 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Shantou Wealy Medical Instrument Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Yangzhou Yichuan Plastic Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 68. All 68 manufacturers in China registered for Container, Liquid Medication, Graduated
Record
| Listed by | Onpharma Company, United States |
|---|---|
| FDA product code | KYW |
| Device type | Container, Liquid Medication, Graduated |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6430 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2020-11-17 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2030-11-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 540-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 57 |
| Bioseal Inc. | Bioseal | 17 |
| Monoject | Cardinal Health | 16 |
| CHS | Canadian Hospital Specialties Ltd. | 15 |
| Marina Medical | Marina Medical Instruments, Inc. | 13 |
| Monoject | Cardinal Health 200, LLC | 13 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 12 |
| Medegen Medical Products, LLC | Medegen Medical Products | 11 |
| BD Oral Syringe | Becton, Dickinson AND Company | 8 |
| V. Mueller | Steris Corporation | 8 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
Showing 12 of 60. All products under Container, Liquid Medication, Graduated
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.