HarmonyCARE
The HarmonyCARE Critical Care Boom is a mobile medical boom designed to fit and perform optimally in the critical care environment, including the Intensive Care Unit.
45manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (12), Guangdong (10). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Arrow Medsource Group Limited | Hongkong | Contract manufacturer | 17 | |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Worldcross Industries Co., Ltd. | Dong Yang | Zhejiang | Contract manufacturer | 3 |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 3 |
| Guangzhou Schauenburg-Truplast Hose Technology Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 45. All 45 manufacturers in China registered for Tubing, Pressure And Accessories
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | BYX |
| Device type | Tubing, Pressure And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5860 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2024-03-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-03-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Critical Care Boom | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ohio | Ohio Medical LLC | 11,388 |
| Western/Scott Fetzer | Western Enterprises, Inc. | 1,364 |
| PC | Allied Medical LLC | 397 |
| Medline | Medline Industries, Inc. | 234 |
| Tubing, Pressure And Accessories | Salter Labs | 120 |
| Hudson RCI | Teleflex Medical LLC | 103 |
| 7000 Connectors | Hans Rudolph, Inc. | 89 |
| CPAP Tubing | Sunset Healthcare Solutions, Inc. | 86 |
| Anesthesia | Sunset Healthcare Solutions, Inc. | 71 |
| Repair Parts | Sunset Healthcare Solutions, Inc. | 38 |
| 2100 3 WAY Stopcock | Hans Rudolph, Inc. | 36 |
| Straight Hose | Maxtec, LLC | 35 |
Showing 12 of 816. All products under Tubing, Pressure And Accessories
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.