AirLife

AirLife® baby safe flow-inflating resuscitation device 1/2 Liter Bag

Registry build 21.09.26
18manufacturers in China registered for this device type
47catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZD
Manufacturer City Province Registered as Device types
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Mehow Innovative (Huizhou) Ltd. Huizhou Guangdong Contract manufacturer 11
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Hunan Beyond Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 3
Shanghai Baron Technologies Co Ltd Shanghai Shanghai Contract manufacturer 3
BMC(Dongguan) Medical Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Zhejiang Baron Technologies Co., Ltd. Pinghu Zhejiang Contract manufacturer 1
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen Sany Pioneer Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Resvent Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6

Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)

Record

Regulatory record for AirLife
Listed by Carefusion, United States
FDA product code BZD
Device type Ventilator, Non-Continuous (Respirator)
Device class Class 2
Regulation 21 CFR 868.5905
Establishment Specification developer, Manufacturer
Record published 2016-09-01
Record revised 2024-05-21 (version 4)

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
Packaging Case of 20, case of 10
Distribution end date 2022-03-31

Catalogue Numbers

Catalogue numbers for AirLife
Catalogue number Size Status
5404L1 Withdrawn
NIV043M Withdrawn
5504BDL1 Withdrawn
NIV044M Withdrawn
5504BGL1 Withdrawn
5424BDL1 Withdrawn
NIV041L Withdrawn
5504DHL1 Withdrawn
NIV044S Withdrawn
5501DL1 Withdrawn
NIV042L Withdrawn
5474BD Withdrawn
5401L1 Withdrawn
NIV043S Withdrawn
5424BDV Withdrawn
5504HL1 Withdrawn
5504BD Withdrawn
5404BDL1 Withdrawn
5404DL1 Withdrawn
5504BDV1 Withdrawn
5514EU Withdrawn
5514RESP Withdrawn
NIV040M Withdrawn
NIV042M Withdrawn
5501L1 Withdrawn
5424BDG1 Withdrawn
NIV042S Withdrawn
NIV044L Withdrawn
5424BD Withdrawn
NIV040L Withdrawn
5504DL1 Withdrawn
5404BD Withdrawn
5524BD Withdrawn
5401BD Withdrawn
5304UCS1 Withdrawn
NIV040S Withdrawn
5501BD Withdrawn
5501HL1 Withdrawn
5504UCL1 Withdrawn
NIV041M Withdrawn
5504B Withdrawn
5511RESP Withdrawn
5504HLV1 Withdrawn
5424D Withdrawn
NIV043L Withdrawn
5524BDH Withdrawn
NIV041S Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DreamStation Respironics Inc. 386
DreamWear Respironics Inc. 183
REMstar System One 60 Series Respironics Inc. 163
Fisher & Paykel Healthcare Fisher & Paykel Healthcare, Ltd. 152
DeVilbiss DeVilbiss Healthcare LLC. 136
Ventilator, Non-Continuous (Respirator) Hans Rudolph, Inc. 115
BiPAP System One 60 Series Respironics Inc. 105
Ventilator, Non-Continuous (Respirator) Salter Labs 85
BiTrac Select Pulmodyne Inc. 79
Yuwell Sleep Apnea Breathing Therapy Mask Suzhou Yuyue Medical Technology Co., Ltd. 76
AF541 Respironics Inc. 71
CPAP Masks Sunset Healthcare Solutions, Inc. 69

Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)

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