Clean Peak Flow Meter

Basic Information

• Brand Name: Clean Peak Flow Meter
• Primary DI: 04057155000306
• Version / Model: Clean Peak Flow Meter - Adults
• 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: 24ddce6f-5f0e-4e64-9c4f-266775988a14
• 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.

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	04057155000306	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			Adult scale: 50 - 800 liters/minutes