Airzone

Basic Information

• Brand Name: Airzone
• Primary DI: 05023323001214
• Version / Model: 3130045
• Catalog Number: 3130045
• Company Name: CLEMENT CLARKE INTERNATIONAL LIMITED
• Labeler DUNS: 216155952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 3
• Public Version Date: 2023-03-27
• Public Version Status: Update
• Public Device Record Key: c0809e9e-b959-40a3-9bf1-6f6810e8130f

Device Description

AIRZONE BLUE ATS (US) SINGLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	868.1860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65366	Expiratory peak flow meter, analogue, reusable	A hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It is in the form of a cylinder with a mouthpiece for exhalation, and a calibrated analogue scale that shows the peak flow value. The device helps to assess pulmonary function in routine tests performed in or outside a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients affected by chronic respiratory disorders (e.g., asthma, emphysema). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05023323001214	GS1
Package	05023323001535	GS1		10	Not in Commercial Distribution	2023-03-24
Package	05023323001542	GS1		10	Not in Commercial Distribution	2023-03-24
Package	05023323002266	GS1		10	In Commercial Distribution
Package	05023323002273	GS1		10	In Commercial Distribution

Customer Contacts

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