FDA.reportPublic FDA data

Curaplex

Primary DI
00812574026214
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-4900EA
Device description
PEAK FLOW METER
Published
2017-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZHMETER, PEAK FLOW, SPIROMETRY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812574026566PackageGS1100In Commercial Distribution
00812574026214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574026566008125740265668125740265660812574026566
00812574026214008125740262148125740262140812574026214

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).

Regulatory Flags#

DUNS number
010712461
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812574025804Curaplex301-P3000EA2016-12-16
00812574025828Curaplex301-P3001EA2016-12-16
00812574025842Curaplex301-P3002EA2016-12-16
00818834020466Curaplex301-180U301-180U2019-02-10
00818834020473Curaplex301-181U301-181U2019-02-10
00818834020480Curaplex301-182U301-182U2019-02-10
00818834020510Curaplex301-189U301-189U2019-02-10
00818834020718Curaplex301-104301-1042019-02-10
00818834020817Curaplex301-122EA301-122EA2019-02-10
00818834020909Curaplex301-170EA301-170EA2019-02-10
00818834020923Curaplex301-180EA301-180EA2019-02-10
00818834020954Curaplex301-181EA301-181EA2019-02-10
00818834020961Curaplex301-182EA301-182EA2019-02-10
00818834020978Curaplex301-183301-1832019-02-10
00818834020985Curaplex301-184301-1842019-02-10
00818834020992Curaplex301-189301-1892019-02-10
00818834021005Curaplex301-191301-1912019-02-10
00812574025811Curaplex301-P3000EA2016-12-14
00812574025835Curaplex301-P3001EA2016-12-14
00812574025859Curaplex301-P3002EA2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042015045FORAFORA CARE INC.BZH2026-05-18
00816042015052FORAFORA CARE INC.BZH2026-05-18
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00198715485813NxGen Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2025-01-27
00311917047201WalgreensWALGREEN CO.BZH2024-03-12
10193489149722HUDSON RCIMEDLINE INDUSTRIES, INC.BZH2024-02-07
20193489149729HUDSON RCIMEDLINE INDUSTRIES, INC.BZH2024-02-07
06975038051017sonmolMufei Tongchuang (Chongqing) Technology Co., LtdBZH2024-01-17
00311917034980WalgreensWALGREEN CO.BZH2023-08-21
10311917034987WalgreensWALGREEN CO.BZH2023-08-21
G004TCPFMA10TenoviTenovi Co.BZH2022-11-01
00642632732050microlifeMICROLIFE USA, INC.BZH2022-06-02
10642632732057microlifeMICROLIFE USA, INC.BZH2022-06-02
05099169439115PFMVITALOGRAPH (IRELAND) LIMITEDBZH2022-04-29
55099169439110PFMVITALOGRAPH (IRELAND) LIMITEDBZH2022-04-29
08908014292010Safey Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2022-02-04
00810025922276caring millCaring MillBZH2021-06-09
10810025922273caring millCaring MillBZH2021-06-09
04897100310162Andnesfit HealthANDESFIT LIMITEDBZH2021-05-03
00840117319035Resp-O2 Peak Flow Meter, Low Range 50-300 L/min, PediatricDynarex CorporationBZH2021-04-22
00840117319042Resp-O2 Peak Flow Meter, Full Range 50-800 L/minDynarex CorporationBZH2021-04-22
00840117318786Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
00840117318793Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
06922649905048M&BBeijing M&B Electronic Instruments Co., Ltd.BZH2021-04-20
06922649905055M&BBeijing M&B Electronic Instruments Co., Ltd.BZH2021-04-20
10884389144558MedlineMEDLINE INDUSTRIES, INC.BZH2021-04-01
40884389144559MedlineMEDLINE INDUSTRIES, INC.BZH2021-04-01
B005001730AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
B005001740AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
B0050017420AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31