AirLife

Basic Information

• Brand Name: AirLife
• Primary DI: 10885403163975
• Version / Model: 001628
• Catalog Number: 001628
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: be783035-768f-4089-84ec-ae5a295ac8d4

Device Description

Airlife™ Universal IPPB Manifold with Right Angle Exhalation Valve and Nebulizer With 39" (1.0 m), 22 mm I.D. Aerosol Tube, Two Supply Lines, Mouthpiece, and 6"(15 cm), 22 mm I.D. Flextube

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32202	Aerosol delivery tubing	A non-sterile length of a flexible, hollow tube, typically large bore (e.g., 22 mm), used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer for the delivery of aerosolized humidification, typically oxygen enriched. It is typically supplied in standard coil lengths and is cut by clinical staff to usable lengths. This is a single-use device.	No	Active
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active
35457	Benchtop nebulizer, non-heated	An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403163973	GS1	Case	50	In Commercial Distribution
Primary	10885403163975	GS1

Customer Contacts

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