FDA.reportPublic FDA data

Resp-O2 Peak Flow Meter Full Range 50-800 L/min

Primary DI
00840117319042
Brand
Resp-O2 Peak Flow Meter Full Range 50-800 L/min
Company
Dynarex Corporation
Model
36111
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K172804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172804000Besmed Peak Flow MeterBesmed Health Business Corp2018-01-11BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117318793PackageGS110In Commercial Distribution
00840117319042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318793008401173187938401173187930840117318793
00840117319042008401173190428401173190420840117319042

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory peak flow meterA hand-held instrument designed to measure the maximum rate of oral or nasal inspiratory gas flow [peak inspiratory flow (PIF) or peak inspiratory flow rate (PIFR)] into the lungs, to assess airway patency. It is in the form of a cylinder with a mouthpiece for inhalation and a calibrated analogue scale that shows the peak flow value; a nasal mask may be attached to the device for evaluating nasal airway patency. It is used during pulmonary function testing as an alternative to rhinomanometry to help diagnose respiratory disorders [e.g., allergic rhinitis, chronic obstructive pulmonary disease (COPD)], or to assess/train medication inhalation technique. This is a reusable device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true

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00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24
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00616784010113Aluminum Crutches - Youth101012019-09-30
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