FDA.reportPublic FDA data

Curaplex

Primary DI
00812574024371
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-5900
Device description
PEAK FLOW METER,CURAPLEX MINIWRIGHT,STANDARD
Published
2016-12-14
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
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
00812574024371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574024371008125740243718125740243710812574024371

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

Regulatory Flags#

DUNS number
010712461
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00810071633096Curaplex8600-014888600-014882021-09-30
00810071633102Curaplex670245-KIT670245-KIT2021-09-30
00818834028400Curaplex301-12230301-122302020-11-30
00818834028424Curaplex301-0903301-09032020-11-30
00812277034509Curaplex1812-020011812-020012019-07-01
00812277034523Curaplex1712-108301712-108302019-07-01
00812277034530Curaplex1712-108351712-108352019-07-01
00812277034547Curaplex1712-158301712-158302019-07-01
00812277034554Curaplex1712-608301712-608302019-07-01
00818834022309Curaplex301-180U301-180U2019-02-10
00818834022316Curaplex301-181U301-181U2019-02-10
00818834022323Curaplex301-182U301-182U2019-02-10
00818834022354Curaplex301-189U301-189U2019-02-10
00818834022361Curaplex301-191U301-191U2019-02-10
00818834022378Curaplex301-192U301-192U2019-02-10
00818834021982Curaplex301-170EA301-170EA2019-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013746407NxGen Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2025-01-27
00198715485813NxGen Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2025-01-27
00311917047201WalgreensWALGREEN CO.BZH2024-03-12
20193489149729HUDSON RCIMEDLINE INDUSTRIES, INC.BZH2024-02-07
06975038051017sonmolChongqing Moffy Innovation Technology Co., Ltd.BZH2024-01-17
10311917034987WalgreensWALGREEN CO.BZH2023-08-21
10642632732057microlifeMICROLIFE USA, INC.BZH2022-06-02
55099169439110PFMVITALOGRAPH (IRELAND) LIMITEDBZH2022-04-29
08908014292010Safey Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2022-02-04
10810025922273caring millCaring MillBZH2021-06-09
04897100310162Andnesfit HealthANDESFIT LIMITEDBZH2021-05-03
00840117318786Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
00840117318793Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
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
00193489019066MedlineMEDLINE INDUSTRIES, INC.BZH2021-03-12
00860000654005AlunaKNOX MEDICAL DIAGNOSTICS INC.BZH2020-09-10
00383730004648OVAL MOUTHPIECERESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDBZH2020-06-11
00383730004624PLASTIC PEDIATRIC MOUTHPIECES (715)100PKRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDBZH2020-06-09
00383730004631PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECERESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDBZH2020-06-09
00383730004617OVAL DISPOSABLE PLASTIC MOUTHPIECERESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDBZH2020-06-05
00383730004563ASTHMACHECKRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTDBZH2020-02-11
08052990321728CoheroMIR SRL MEDICAL INTERNATIONAL RESEARCHBZH2020-02-07
06970397220012SpiroLinkGuangzhou Red Elephant Medical Technology Co.,LtdBZH2019-12-19
00850002860382Clever Choice Peak Flow MeterSIMPLE DIAGNOSTICS INCBZH2019-11-04
00146191010005AndesfitANDESFIT LIMITEDBZH2019-09-09
05023323000293AbleCLEMENT CLARKE INTERNATIONAL LIMITEDBZH2019-06-06
34250892904468VyaireVyaire Medical GmbHBZH2019-03-19