FDA.reportPublic FDA data

Omron Peak A-I-R Peak Flow Meter

Primary DI
00073796699406
Brand
Omron Peak A-I-R Peak Flow Meter
Company
Omron Healthcare, Inc.
Model
PF9940
Catalog number
PF9940
Device description
Peak Flow Meter for Adult / Pediatric
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZHMeter, Peak Flow, Spirometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZHMeter, Peak Flow, SpirometryAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982334000AIRZONE PEAK FLOWMETERClement Clarke Intl., Ltd.1999-01-14BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796699403PackageGS16In Commercial Distribution
20073796699400PackageGS112In Commercial Distribution
00073796699406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379669940310073796699403
2007379669940020073796699400
00073796699406000737966994060737966994060073796699406

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, manualA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-4350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true

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