Hanwell

Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made…

Registry build 21.09.26

Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made from medical grade Silicone, have good biocompatibility. Provide a good seal when fitted to the patient. Features a 360 degree dual swivel elbow port to move freely. The ultra-flexible forehead support reduces contact with your skin.

46manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (22), Guangdong (7), Jiangsu (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BYF
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Ningbo Mflab Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105

Showing 12 of 46. All 46 manufacturers in China registered for Mask, Oxygen, Low Concentration, Venturi

Record

Regulatory record for Hanwell
Listed by Ningbo Hanyue Medical Technology Co., Ltd., China
FDA product code BYF
Device type Mask, Oxygen, Low Concentration, Venturi
Device class Class 1
Regulation 21 CFR 868.5600
Establishment Contract manufacturer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-10-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Labelled latex-free
Label carries manufacturing date

Catalogue Numbers

Catalogue numbers for Hanwell
Catalogue number Size Status
M In distribution
S In distribution
L In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Venticaire Lite Flexicare Medical Ltd. 91
Hudson RCI Teleflex Medical LLC 21
Mask, Oxygen, Low Concentration, Venturi Salter Labs 16
CPAP Kit Sunset Healthcare Solutions, Inc. 9
Pegasus Pegasus Research Corp. 6
Medline Medline Industries, Inc. 4
Lightning X Products,Inc Wuxi Emsrun Technology Co., Ltd. 2
Aerosol & Nebs Sunset Healthcare Solutions, Inc. 2
Venturi Mask Adult W/6 Diluters, W/7FT Tubing, 6 Inch Corrugate Tube Besmed Health Business Corporation 2
Resp-O2 Venturi Select A Vent Elongated Mask Dynarex Corp. 2
Resp-O2 Venturi Adjustable Dial Elongated Mask Dynarex Corp. 2
Rhino Rescue Wuxi Emsrun Technology Co., Ltd. 2

Showing 12 of 68. All products under Mask, Oxygen, Low Concentration, Venturi

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer