Resp-O2 Peak Flow Meter

Primary DI
00840117318793
Brand
Resp-O2 Peak Flow Meter
Company
DYNAREX CORPORATION
Model
36111
Device description
Resp-O2 Peak Flow Meters Full Range 50-800 l/min
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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