AirLife™

LVN Kit, Face Tent Mask with 6’Corrugated Tube

Registry build 21.09.26
1manufacturer
9catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OGG
Manufacturer City Province Registered as Device types
Avita (Wujiang) Co., Ltd. Wujiang Jiangsu Contract manufacturer 15

Record

Regulatory record for AirLife™
Listed by Airlife, Inc., United States
FDA product code OGG
Device type Humidifier Nebulizer Kit
Device class Class 2
Regulation 21 CFR 868.5450
Premarket notification Exempt
Record published 2021-03-26
Record revised 2025-09-24 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Storage environment temperature up to 25 °C; Special storage condition: Protect from freezing
Packaging Case of 12, pack of 10

Catalogue Numbers

Catalogue numbers for AirLife™
Catalogue number Size Status
CK4505 In distribution
CK4510 In distribution
CK0005 In distribution
CK4505 In distribution
SPK100128E In distribution
CK0010 In distribution
CK4510 In distribution
RES441676D In distribution
CK0010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hudson RCI Teleflex Medical LLC 156
Hudson RCI Medline Industries, Inc. 12
AirLife Carefusion 10
Yirdoc Qingdao Future Medical Technology Co., Ltd. 4
Medline Industries, Inc. Medline Industries, Inc. 2
Composite Respiratory Kit Westmed, Inc. 1
Seattle PAP plus Drägerwerk AG & Co. KGaA 1
Curaplex Bound Tree Medical, LLC 1

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