FDA.reportPublic FDA data

Micro

Primary DI
15099169633305
Brand
Micro
Company
VITALOGRAPH (IRELAND) LIMITED
Model
6300
Device description
6300 MICRO BLUETOOTH INTERNATIONAL WEST(1)
Published
2017-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZGSPIROMETER, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160253000Vitalograph Model 6300 microVitalograph (Ireland) , Ltd.2016-08-26BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05099169633308PackageGS11In Commercial Distribution
15099169633305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05099169633308050991696333085099169633308
1509916963330515099169633305

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
219683489
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851845007248comPAS291704917042026-06-03
050991693321579100 VITALOGRAPH VitaloLAB+91510915102026-06-02
15099169203102Mouthpiece20202020-06-21
15099169283814PFT28202016-12-01
15099169283821PFT28202016-12-01
050991698301272120 In2itive - Brazil83012830122025-04-30
05099169770508Pneumotrac68002017-11-15
05099169919105VitaloROV91002024-07-31
15099169331898Mouthpiece20202024-04-08
15099169203928Mouthpiece20202018-05-15
15099169251004Aspirator25102018-05-09
65099169688003SPIROTRAC70002021-04-30
15099169202013Mouthpiece20202016-12-08
15099169202020Mouthpiece20202018-05-15
15099169202426Safe-T-Way20242016-12-08
15099169202464Safe-T-Way20242016-12-08
15099169209203Safe-T-Way20242016-12-08
15099169209227Safe-T-Way20242016-12-08
15099169209241Safe-T-Way20242016-12-08
15099169209296Safe-T-Way20242018-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851845007248comPAS2VITALOGRAPH (IRELAND) LIMITEDBZG2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZG2026-06-02
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
08052990320288MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320363MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320431MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320455MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320462MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320509MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320516MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320547MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320554MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
14250892909117JaegerJaeger Medical GmbHBZG2025-08-11
07613365501193PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501209PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
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07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501247PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20