Gentec®

CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient's inhalation, and other…

Registry build 21.09.26

CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient’s inhalation, and other medical devices’ flow control and monitor as well.

45manufacturers in China registered for this device type
28catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (14), Jiangsu (12), Guangdong (10). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BYX
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Arrow Medsource Group Limited Hongkong Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11
Worldcross Industries Co., Ltd. Dong Yang Zhejiang Contract manufacturer 3
Yangzhong Meidi Medical Products Co., Ltd. Yangzhong Jiangsu Contract manufacturer 3
Guangzhou Schauenburg-Truplast Hose Technology Ltd. Guangzhou Guangdong Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263

Showing 12 of 45. All 45 manufacturers in China registered for Tubing, Pressure And Accessories

Record

Regulatory record for Gentec®
Listed by Gentec (Shanghai) Corporation, China
FDA product code BYX
Device type Tubing, Pressure And Accessories
Device class Class 1
Regulation 21 CFR 868.5860
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-08-01
Record revised 2024-12-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Latex Labelled latex-free
Label carries manufacturing date, serial number
Distribution end date 2034-08-04
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Gentec®
Catalogue number Size Status
34U-OXY In distribution
35U-VAC Series In distribution
35U-AIR Series In distribution
35U-N2O Series In distribution
CFM-25L In distribution
CFM-15L In distribution
34U-N2O Series In distribution
35U-OXY Series In distribution
35I-N2O Series In distribution
34U-OXY Series In distribution
35I-CO2 Series In distribution
Y-VAC-CPLR-OH In distribution
34I-VAC Series In distribution
34U-AIR Series In distribution
Y-OXY-CPLR-OH In distribution
FM-PTO In distribution
35I-AIR Series In distribution
34U-VAC Series In distribution
35U-CO2 Series In distribution
34I-AIR Series In distribution
34I-CO2 Series In distribution
35I-VAC Series In distribution
34I-OXY Series In distribution
34I-N2O Series In distribution
Y-VAC-CPLR-DH In distribution
35I-OXY Series In distribution
34U-CO2 Series In distribution
CFM Series In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ohio Ohio Medical LLC 11,388
Western/Scott Fetzer Western Enterprises, Inc. 1,364
PC Allied Medical LLC 397
Medline Medline Industries, Inc. 234
Tubing, Pressure And Accessories Salter Labs 120
Hudson RCI Teleflex Medical LLC 103
7000 Connectors Hans Rudolph, Inc. 89
CPAP Tubing Sunset Healthcare Solutions, Inc. 86
Anesthesia Sunset Healthcare Solutions, Inc. 71
Repair Parts Sunset Healthcare Solutions, Inc. 38
2100 3 WAY Stopcock Hans Rudolph, Inc. 36
Straight Hose Maxtec, LLC 35

Showing 12 of 816. All products under Tubing, Pressure And Accessories

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