FDA.report

AsthmaMD

Primary DI
20857818006014
Brand
AsthmaMD
Company
GENIA MEDICAL, INC.
Model
G0001-K001
Device description
Peak Flow Meter
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZHMeter, Peak Flow, Spirometry

Product Code Classifications

CodeDeviceSpecialtyClass
BZHMeter, Peak Flow, SpirometryAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10857818006017PackageGS110In Commercial Distribution
20857818006014PackageGS160In Commercial Distribution
00857818006010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085781800601710857818006017
2085781800601420857818006014
00857818006010008578180060108578180060100857818006010

GMDN Terms

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).

Sterilization Methods

Method

Regulatory Flags

DUNS number
080212500
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00860000654005AlunaKNOX MEDICAL DIAGNOSTICS INC.BZH2020-09-10
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08052990321728CoheroMIR SRL MEDICAL INTERNATIONAL RESEARCHBZH2020-02-07
06970397220012SpiroLinkGuangzhou Red Elephant Medical Technology Co.,LtdBZH2019-12-19
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05023323000293AbleCLEMENT CLARKE INTERNATIONAL LIMITEDBZH2019-06-06
34250892904468VyaireVyaire Medical GmbHBZH2019-03-19