AirLife™

AirLife™ Isothermal™ Breathing Circuit Accessory - Infant Patient Connector w/Suction Port and Strap Plug Special Product Request - Infant Patient Connector w/ Suction Port and Strap Plug

Registry build 21.09.26
20manufacturers in China registered for this device type
66catalogue numbers in this listing
11510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (7), Jiangsu (6), Zhejiang (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZA
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
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Dongguan Junhai Medical Device Co., Ltd. Dong Guang Guangdong Contract manufacturer 9
Shanghai Draeger Medical Instrument Co., Ltd. Shanghai Shanghai Contract manufacturer 4
Suzhou Yuyue Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33

Showing 12 of 20. All 20 manufacturers in China registered for Connector, Airway (Extension)

Record

Regulatory record for AirLife™
Listed by Airlife, Inc., United States
FDA product code BZA
Device type Connector, Airway (Extension)
Device class Class 1
Regulation 21 CFR 868.5810
Premarket notification Exempt
Record published 2025-03-27
Record revised 2025-04-17 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Case of 50, case of 150, case of 30, case of 10, case of 6, case of 25
Sizes Length 6 ft
Distribution end date 2026-01-05

Catalogue Numbers

Catalogue numbers for AirLife™
Catalogue number Size Status
001803 In distribution
0P1775 In distribution
004081 In distribution
001793 In distribution
3215 In distribution
001821 In distribution
5920-504 In distribution
3215-504G In distribution
001830 In distribution
5917-504 In distribution
5157EU In distribution
5918-504 In distribution
004050 In distribution
5156EU In distribution
5999-504 In distribution
004225 In distribution
001218 In distribution
5916-504 In distribution
004078 In distribution
004000 In distribution
4920-504 In distribution
001505 In distribution
004084 In distribution
001823 In distribution
3222-504G In distribution
001811 In distribution
5915-504 In distribution
001824 In distribution
5913-504 In distribution
0Y1777 In distribution
155200EU In distribution
5903-504 In distribution
001503 In distribution
004379 In distribution
5940-504 In distribution
5924-504 In distribution
004204 In distribution
004080 In distribution
004052 In distribution
4826-504 Length 6 ft In distribution
001794 In distribution
5995-504 In distribution
3222 In distribution
004083 In distribution
5157EU In distribution
5941-504 In distribution
5912-504 In distribution
5923-504 In distribution
5939-504 In distribution
004051 In distribution
001820 In distribution
5930-504 In distribution
132410 In distribution
0Y1779 In distribution
004301 In distribution
001801 In distribution
5930-504 In distribution
004154 In distribution
5925-504 In distribution
5991-504 In distribution
004011 In distribution
5911-504 In distribution
001822 In distribution
3215-504G In distribution
001841 Withdrawn
001842 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AincA® Anesthesia Associates, Inc. 158
Hudson RCI Teleflex Medical LLC 126
DAR Covidien LP 65
Connector, Airway (Extension) VBM Medizintechnik Gmbh 58
Medline Industries, Inc. Medline Industries, Inc. 24
Connector, Airway (Extension) Galemed Corp. 23
Vital Signs™ AirLife Finland Oy 22
Airway Adapters Respironics Novametrix, LLC 19
Oxygen Connector/Adapter Sunset Healthcare Solutions, Inc. 18
Flexicare Flexicare Medical Ltd. 15
Adaptors/Connectors Westmed, Inc. 15
Flex Connector King Systems Corporation. 14

Showing 12 of 279. All products under Connector, Airway (Extension)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K812067 1981-08-12
K811890 1981-07-15
K811708 1981-07-01
K802663 1980-11-12
K790888 1979-06-27
K790887 1979-06-05
K790156 1979-04-20
K790155 1979-02-01
K790157 1979-02-01
K790149 1979-02-01
K790148 1979-02-01

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