CPAP Mask Cushion

Replacement Cushion for Sunset Vesper Full Face CPAP Mask - Small

Registry build 21.09.26
18manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZD
Manufacturer City Province Registered as Device types
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Mehow Innovative (Huizhou) Ltd. Huizhou Guangdong Contract manufacturer 11
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Hunan Beyond Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 3
Shanghai Baron Technologies Co Ltd Shanghai Shanghai Contract manufacturer 3
BMC(Dongguan) Medical Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Zhejiang Baron Technologies Co., Ltd. Pinghu Zhejiang Contract manufacturer 1
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen Sany Pioneer Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Resvent Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6

Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)

Record

Regulatory record for CPAP Mask Cushion
Listed by Sunset Healthcare Solutions, Inc., United States
FDA product code BZD
Device type Ventilator, Non-Continuous (Respirator)
Device class Class 2
Regulation 21 CFR 868.5905
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K203347
Record published 2025-07-17
Record revised 2026-04-23 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number
Packaging Pack of 20

Catalogue Numbers

Catalogue numbers for CPAP Mask Cushion
Catalogue number Size Status
CUCM206S In distribution
PH0210 In distribution
ASCM002CUCM005S In distribution
PH0212 In distribution
PH0310 In distribution
CUCM205L In distribution
CUCM110M In distribution
PH0211 In distribution
ASCM002CUCM005M In distribution
PH0311 In distribution
PH0312 In distribution
CUCM006S In distribution
CUCM205S In distribution
CUCM110S In distribution
PH0411 In distribution
CUCM206L In distribution
ASCM002CUCM006L In distribution
PH0410 In distribution
CUCM110L In distribution
ACM002CUCM005M In distribution
CUCM206M In distribution
ASCM002CUCM005L In distribution
PH0412 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DreamStation Respironics Inc. 386
DreamWear Respironics Inc. 183
REMstar System One 60 Series Respironics Inc. 163
Fisher & Paykel Healthcare Fisher & Paykel Healthcare, Ltd. 152
DeVilbiss DeVilbiss Healthcare LLC. 136
Ventilator, Non-Continuous (Respirator) Hans Rudolph, Inc. 115
BiPAP System One 60 Series Respironics Inc. 105
Ventilator, Non-Continuous (Respirator) Salter Labs 85
BiTrac Select Pulmodyne Inc. 79
Yuwell Sleep Apnea Breathing Therapy Mask Suzhou Yuyue Medical Technology Co., Ltd. 76
AF541 Respironics Inc. 71
CPAP Masks Sunset Healthcare Solutions, Inc. 69

Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)

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