FDA.reportPublic FDA data

Pneumotrac

Primary DI
15099169770529
Brand
Pneumotrac
Company
VITALOGRAPH (IRELAND) LIMITED
Model
6800
Device description
6800 PNEUMOTRAC-C(1)
Published
2017-11-15
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
K142812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142812000Vitalograph Model 6800 PneumotracVitalograph (Ireland) , Ltd.2015-06-29BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05099169770522PackageGS11In Commercial Distribution
15099169770529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05099169770522050991697705225099169770522
1509916977052915099169770529

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

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
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08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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