Clean Peak Flow Meter

Basic Information

• Brand Name: Clean Peak Flow Meter
• Primary DI: 04057155000313
• Version / Model: Clean Peak Flow Meter - Children
• Company Name: eResearchTechnology GmbH
• Labeler DUNS: 341625331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-01
• Public Version: 5
• Public Version Date: 2021-12-31
• Public Version Status: Update
• Public Device Record Key: febbaef9-f9a0-42ad-899b-2eafab2e3b78
• Distribution End Date: 2021-12-31

Device Description

The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum velocity of air expelled from the lungs. The children model is intended for patients from 6 years on up to 12 years.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
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	04057155000313	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091412	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Children scale: 50 - 380 liters/minutes