SpiroFlow

Basic Information

• Brand Name: SpiroFlow
• Primary DI: 00855784004016
• Version / Model: E5010
• Catalog Number: E5010-2
• Company Name: Spirometrics
• Labeler DUNS: 830864406
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 4
• Public Version Date: 2020-09-24
• Public Version Status: Update
• Public Device Record Key: e48c13de-94e5-40cc-b7a9-22db1357e023
• Distribution End Date: 2020-08-28

Device Description

Adult Peak Flow 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: No
• 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: 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
46872	Peak flow meter, manual	A manual, 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 typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of 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 suffering from chronic respiratory disorders (e.g., asthma, emphysema).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855784004030	GS1	box	8	Not in Commercial Distribution	2020-08-28
Package	00855784004221	GS1	box	12	Not in Commercial Distribution	2020-08-28
Primary	00855784004016	GS1
Package	00855784004023	GS1	box	2	Not in Commercial Distribution	2020-08-28

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K915059	000