MIR

Basic Information

• Brand Name: MIR
• Primary DI: 08052990321681
• Version / Model: Smart One USA
• Company Name: MIR MEDICAL INTERNATIONAL RESEARCH SPA
• Labeler DUNS: 630129930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-22
• Public Version: 5
• Public Version Date: 2024-01-12
• Public Version Status: Update
• Public Device Record Key: 74f0f86e-07c2-45c6-96d4-e11927fcf0b7

Device Description

Peak low and FEV1 meter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	868.1860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46906	Expiratory peak flow meter, digital	A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08052990321681	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181666	000