Asthma Monitor AM3

Basic Information

• Brand Name: Asthma Monitor AM3
• Primary DI: 04057155000207
• Version / Model: AM3 G+
• Company Name: eResearchTechnology GmbH
• Labeler DUNS: 341625331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-04
• Public Version: 2
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: 896a87cb-8905-4c9d-87fa-b43686489d43

Device Description

Asthma Monitor, electronic peak flow meter with TCP/IP

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	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	04057155000207	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183479	000