AirLife

Basic Information

• Brand Name: AirLife
• Primary DI: 10885403199158
• Version / Model: CK9010
• Catalog Number: CK9010
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 7
• Public Version Date: 2025-09-24
• Public Version Status: Update
• Public Device Record Key: f4206763-e50c-435b-8f54-44d23986f8ce
• Distribution End Date: 2022-03-31

Device Description

Airlife™ Prefill Nebulizer Kit Nebulizer Cap and 0.9% Sodium Chloride Sterile Inhalation Solution, USP 1000ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGG	Humidifier nebulizer kit	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35457	Therapeutic agent nebulizer, benchtop	An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.	No	Active
44643	Intravenous/irrigation solution storage container, single-use	An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403199156	GS1	Case	12	Not in Commercial Distribution	2022-03-31
Primary	10885403199158	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]