AirLife™

AirLife™ Pediatric Dual Dial Venturi Style Mask With 6 inch (15 cm) Flextube, Color Coded Low and Medium Concentration Dials, High Humidity Adapter / Humidification Hood, 7 foot (2.1 m)…

Registry build 21.09.26

AirLife™ Pediatric Dual Dial Venturi Style Mask With 6 inch (15 cm) Flextube, Color Coded Low and Medium Concentration Dials, High Humidity Adapter / Humidification Hood, 7 foot (2.1 m) Crush Resistant Oxygen Tubing

97manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (33), Guangdong (23), Jiangsu (17). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAT
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Hitec Medical Co., Ltd. Shanghai Shanghai 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
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Ningbo Mflab Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11

Showing 12 of 97. All 97 manufacturers in China registered for Cannula, Nasal, Oxygen

Record

Regulatory record for AirLife™
Listed by Vyaire Medical, Inc., United States
FDA product code CAT
Device type Cannula, Nasal, Oxygen
Device class Class 1
Regulation 21 CFR 868.5340
Premarket notification Exempt
Record published 2020-01-15
Record revised 2022-11-28 (version 3)

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
Storage Storage environment temperature 0 to 50 °C
Packaging Case of 50, case of 25, case, case of 15, 1, case of 500

Catalogue Numbers

Catalogue numbers for AirLife™
Catalogue number Size Status
002707 In distribution
001207 In distribution
001211 In distribution
001309 In distribution
001244 In distribution
001405 In distribution
001363 In distribution
001550 In distribution
001365 In distribution
001361 In distribution
001265 In distribution
002602 In distribution
001450 In distribution
001320 In distribution
001302 In distribution
001269 In distribution
001304 In distribution
001247 In distribution
001404 In distribution
001208 In distribution
001350 In distribution
001322 In distribution
001261 In distribution
001330 In distribution
001303 In distribution
001210 In distribution
001329 In distribution
001268 In distribution
002016 In distribution
001200 In distribution
001326 In distribution
001255 In distribution
001321 In distribution
001500 In distribution
001000 In distribution
001362 In distribution
001259 In distribution
001240 In distribution
001400 In distribution
001267 In distribution
002611 In distribution
001325 In distribution
001245 In distribution
001311 In distribution
001420 In distribution
001410 In distribution
001262 In distribution
001426 In distribution
001366 In distribution
001220 In distribution
001840 In distribution
001263 In distribution
001504 In distribution
001212 In distribution
001507 In distribution
001327 In distribution
001221 In distribution
001250 In distribution
001306 In distribution
001421 In distribution
001305 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cannula, Nasal, Oxygen Salter Labs 394
Hudson RCI Teleflex Medical LLC 92
Medline Medline Industries, Inc. 53
AirLife™ Airlife, Inc. 51
Hudson RCI Medline Industries, Inc. 44
Vapotherm Vapotherm Inc. 41
Curaplex Bound Tree Medical, LLC 39
McKesson Mckesson Medical-Surgical Inc. 38
Curaplex TRI-Anim Health Services, Inc. 35
Create Biotech Create Biotech Co., Ltd. 34
ProCure Twin Med, LLC 32
Oxygen Kit Sunset Healthcare Solutions, Inc. 32

Showing 12 of 402. All products under Cannula, Nasal, Oxygen

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