Rapid Oxygen R15

The R-15 oxygen generator provides on-demand oxygen delivered to the subject using an oxygen facemask. The R-15 oxygen generator consists of housing containing the oxygen generating…

Registry build 21.09.26

The R-15 oxygen generator provides on-demand oxygen delivered to the subject using an oxygen facemask. The R-15 oxygen generator consists of housing containing the oxygen generating chemical in mesh pouches, reaction regulating sealed liquid containing pouches, a lid, a water bag and a valve assembly with a compartment for the catalyst. The oxygen producing chemical, catalyst and water are isolated from each other during storage by placing each in separated sealed compartments. The compartments are connected by a valve that upon activation allows the water to flow through a chamber in the valve containing the catalyst and into the compartment in the housing with the mixture. The water distributes the catalyst through the compartment and submerses the oxygen generating chemical mixture and a portion of the sealed pouches. When the hydrogen peroxide contacts MnO2, the hydrogen peroxide is decomposed catalytically to water and oxygen.

22manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (6), Guangdong (5), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAW
Manufacturer City Province Registered as Device types
Foshan Kycare Medical Equipment Co., Ltd. Foshan Guangdong Contract manufacturer 3
Jakamed Instruments Co., Ltd. Changsha Hunan Contract manufacturer 2
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu Jiangsu Contract manufacturer 17
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Danyang Huayi Medical Supply & Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 11
Shandong Moonlight Electronics Tech Co., Ltd. Weifang Shandong Manufacturer 11
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
Beijing Choicemmed Technology Co., Ltd. Beijing Beijing Repacker / relabeller 9
Foshan Care Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 3
Zhengzhou Olive Electronic Technology Co., Ltd. Zhengzhou Henan Manufacturer 3

Showing 12 of 22. All 22 manufacturers in China registered for Generator, Oxygen, Portable

Record

Regulatory record for Rapid Oxygen R15
Listed by Rapid Oxygen Inc
FDA product code CAW
Device type Generator, Oxygen, Portable
Device class Class 2
Regulation 21 CFR 868.5440
510(k) K033863
Record published 2018-12-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 40 to 104 °F

Catalogue Numbers

Catalogue numbers for Rapid Oxygen R15
Catalogue number Size Status
R15 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeVilbiss DeVilbiss Healthcare LLC. 50
EverFlo Respironics Inc. 32
Mark 5 Nuvo Lite Nidek Medical Products, Inc. 30
SimplyGo Mini Respironics Inc. 26
X-PLO2R Belluscura, LLC 17
Mark 5 Nuvo 8 Nidek Medical Products, Inc. 12
ViveBreathe Vive Health LLC 11
Invacare® HomeFill® Oxygen System Invacare GmbH 11
Discov-R Belluscura, LLC 11
NewLife Elite Caire Inc. 10
NewLife Elite Airsep Corp. 10
Rhythm Healthcare Qingdao Kingon Medical Science AND Technology Co., Ltd. 9

Showing 12 of 187. All products under Generator, Oxygen, Portable

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