FDA.reportPublic FDA data

TruPeak®

Primary DI
50604351915102
Brand
TruPeak®
Company
MONAGHAN MEDICAL CORPORATION
Model
Peak Flow Meter, cs/10
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K031514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031514000MODIFICATION TO TRUPEAK PEAK FLOW METERMonaghan Medical Corp.2003-05-23BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50604351915102PackageGS110In Commercial Distribution
00604351915107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435191510250604351915102
00604351915107006043519151076043519151070604351915107

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
518-561-7330customerservice@monaghanmed.com

Regulatory Flags#

DUNS number
056332380
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00604351673106MC 300 Reusable NebulizerMC3002026-05-26
00604351506121Aerochamber2go Anti-Static Valved Holding ChamberAeroChamber2go, cs/122025-05-30
00604351505124Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351707061Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351707066Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351505129Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351350014Nasoneb®NasoNeb Compressor2024-04-09
00604351504127Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
50604351504122Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
00604351501126Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
00604351502123Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
00604351503120Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351500129Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, cs/122023-11-14
50604351501121Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
50604351502128Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
50604351503125Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351886858MonaghanKit, Educational, MMC Z STAT™ aVHC886852018-10-12
00604351788015Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, NFR, Single2016-10-10
00604351798014Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, NFR, Single2016-10-10
00604351808010Aerochamber Plus® Flow-Vu®aVHC, Large Mask, NFR, Single2016-10-10

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