FDA.reportPublic FDA data

Spiro Handle

Primary DI
08809276943729
Brand
Spiro Handle
Company
Bionet CO,LTD
Model
Spiro Handle
Device description
SPIROMETER, DIAGNOSTIC
Published
2021-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130322000SPM-300Bionet Co., Ltd.2013-11-15BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809276943726PackageGS14In Commercial Distribution
08809276943729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927694372618809276943726
08809276943729088092769437298809276943729

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometer, professionalAn electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.

Regulatory Flags#

DUNS number
689708212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809276943958Cardio Q50, Cardio Q70Cardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Cardio Q702026-05-26
08809276943972Cardio P1Cardio P12026-05-26
08809276944269Cardio Q50, Cardio Q70CardioExpress 40122026-05-26
08809276944276Cardio Q50, Cardio Q70CardioExpress 50122026-05-26
08809276943552Cardio7Cardio72021-07-15
08809276940285CardioXPCardioXP2021-07-15
08809276943538CardioCare2000CardioCare20002021-07-15
08809276943545CardioTouch3000CardioTouch30002021-07-15
08809276943590FC700FC7002021-07-15
08809276943606FC1400FC14002021-07-15
08809276943644BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276940282CardioXPCardioXP2021-07-15
18809276943535CardioCare2000CardioCare20002021-07-15
18809276943542CardioTouch3000CardioTouch30002021-07-15
18809276943559Cardio7Cardio72021-07-15
18809276943597FC700FC7002021-07-15
18809276943603FC1400FC14002021-07-15
18809276943641BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276943726Spiro HandleSpiro Handle2021-07-15

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Primary DI, Brand, Company table
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07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
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