SureFlow

5 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50…

Registry build 21.09.26

5 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.

5manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BXY
Manufacturer City Province Registered as Device types
Danyang Xinya Valve Co., Ltd. Danyang Jiangsu Contract manufacturer 17
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Danyang Airtech Co., Ltd. Danyang Jiangsu Contract manufacturer 7
Yuyao Jiahua Medical Appliance, Co., Ltd. Yuyao Zhejiang Manufacturer 5
Foshan Kycare Medical Equipment Co., Ltd. Foshan Guangdong Contract manufacturer 3

Record

Regulatory record for SureFlow
Listed by Caire Inc., United States
FDA product code BXY
Device type Flowmeter, Calibration, Gas
Device class Class 1
Regulation 21 CFR 868.2350
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2019-05-30
Record revised 2019-05-07 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for SureFlow
Catalogue number Size Status
FM069-5 In distribution
FM069-1 In distribution
FM069-2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Manifold Maxtec, LLC 10
DFB Flowmeter Maxtec, LLC 10
Acrylic Flowmeter Maxtec, LLC 10
EM Allied Medical LLC 6
Flowmeter Maxtec, LLC 4
BlenderBuddy Maxtec, LLC 3
Repair Parts Sunset Healthcare Solutions, Inc. 3
Responsive Respiratory, Inc. Responsive Respiratory Inc. 3
Flowmeter, Calibration, Gas Salter Labs 3
Flowmeter Manifold Maxtec, LLC 3
Flotec Flotec, Inc. 1
Flow Sensor, Adult Besmed Health Business Corporation 1

Showing 12 of 29. All products under Flowmeter, Calibration, Gas

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