O-Two

The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without…

Registry build 21.09.26

The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without turbulence and create a differential pressure in two points which are connected to differential pressure sensor used to calculate flow. The unique one-way check valve will only allow flow from ventilator to patient and prevent the exhaled flow flowing back to the ventilator. All exhaled flow will be forced out to the atmosphere through the exhausted port of the breathing valve. The 01CV8030 is specifically designed for use with o_two e700, e600 and e500 electronic transport ventilators.

55manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAI
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian 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
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Flying Tooling Engineering Limited Dongguan Guangdong Contract manufacturer 9
Hangzhou Formed Medical Devices Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9

Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)

Record

Regulatory record for O-Two
Listed by O-TWO Medical Technologies, Inc., Canada
FDA product code CAI
Device type Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class Class 1
Regulation 21 CFR 868.5240
Establishment Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-05-31
Record revised 2022-10-24 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature -20 to 60 °C
Packaging Pack of 10
Sizes Weight 80 to 260 g; length 40 in; length 6 to 10 ft

Catalogue Numbers

Catalogue numbers for O-Two
Catalogue number Size Status
01CV8030 Weight 260 g In distribution
01CV8015 Length 40 in In distribution
01CV8010 Weight 80 g In distribution
01CV8016 Length 10 ft In distribution
01CV8019 Weight 80 g In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Industries, Inc. Medline Industries, Inc. 3,457
Vital Signs™ Airlife, Inc. 1,018
Hudson RCI Teleflex Medical LLC 176
Vital Signs™ AirLife Finland Oy 143
Universal F2®ANESTHESIA Breathing Circuit King Systems Corporation. 133
Universal FLEX2®BREATHING Circuit King Systems Corporation. 123
Adult Ultra Flex®anesthesia Breathing Circuit King Systems Corporation. 111
Portex ICU Medical, Inc 95
AincA® Anesthesia Associates, Inc. 76
Medline/MMS Sales Medline Industries, Inc. 73
Pediatric Ultra Flex®anesthesia Breathing Circuit King Systems Corporation. 71
Vital Signs™ Vyaire Medical, Inc. 70

Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)

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