What is FDA product code OGG?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Anesthesiology › TherapeuticHumidifier Nebulizer Kit

AirLife

Name: AirLife
Brand: AirLife

Airlife™ Prefill Nebulizer Kit Nebulizer Cap and 0.45% Sodium Chloride Sterile Inhalation Solution, USP, 1000 ml

Registry build 21.09.26

1manufacturer

10catalogue 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	Carefusion, United States
FDA product code	OGG
Device type	Humidifier Nebulizer Kit
Device class	Class 2
Regulation	21 CFR 868.5450
Establishment	Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2016-09-01
Record revised	2025-09-24 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 12, case of 50, case of 16, case of 10
Distribution end date	2022-03-31

Catalogue Numbers

Catalogue numbers for AirLife
Catalogue number	Size	Status
CK9010		Withdrawn
ANEV20110A		Withdrawn
RES733726A		Withdrawn
CK4505		Withdrawn
RESNKBT01A		Withdrawn
CK0005		Withdrawn
RES543464D		Withdrawn
CK0010		Withdrawn
CK4510		Withdrawn
RES441676D		Withdrawn

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™	Airlife, Inc.	9
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.