Sunmed
KIT, Mask, Flex Cpap, #6, X-Large Adult / Harness, Single
71manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (27), Guangdong (16), Jiangsu (8). 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 71. All 71 manufacturers in China registered for Mask, Gas, Anesthetic
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | BSJ |
| Device type | Mask, Gas, Anesthetic |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-22 |
| Record revised | 2022-02-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Storage environment atmospheric pressure from 0 KiloPascal; Storage environment temperature 0 to 0 °C; Handling environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 712-0015-00 | In distribution | |
| 912-0011-20 | In distribution | |
| 712-0014-00 | In distribution | |
| 912-0009-20 | In distribution | |
| 721-0013-00 | In distribution | |
| 912-0010-20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 205 |
| Medline | Medline Industries, Inc. | 49 |
| Rusch | Teleflex Medical LLC | 45 |
| Portex | ICU Medical, Inc | 33 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
| AincA® | Anesthesia Associates, Inc. | 29 |
| Hudson RCI | Teleflex Medical LLC | 27 |
| Deluxe Full Face Mask | Mercury Medical Enterprises, LLC | 27 |
| King Mask | Ambu A/S | 26 |
| Mask, Gas, Anesthetic | VBM Medizintechnik Gmbh | 23 |
| Cardinal Health | Cardinal Health 200, LLC | 23 |
| Vital Signs™ | Airlife, Inc. | 19 |
Showing 12 of 270. All products under Mask, Gas, Anesthetic
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.