Spirotrac

Primary DI
65099169686740
Brand
Spirotrac
Company
VITALOGRAPH (IRELAND) LIMITED
Model
7000
Device description
68674 software
Published
2016-12-14
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
K141546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141546000VITALOGRAPH MODEL 7000 SPIROTRACVitalograph (Ireland) , Ltd.2014-09-03BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05099169706019PackageGS11In Commercial Distribution
05099169706026PackageGS11Not in Commercial Distribution
05099169706040PackageGS11Not in Commercial Distribution
05099169706057PackageGS11Not in Commercial Distribution
05099169706064PackageGS11Not in Commercial Distribution
05099169706071PackageGS11In Commercial Distribution
05099169706118PackageGS11In Commercial Distribution
05099169706125PackageGS11Not in Commercial Distribution
05099169706156PackageGS11Not in Commercial Distribution
05099169706194PackageGS11In Commercial Distribution
15099169676715PackageGS115In Commercial Distribution
15099169676722PackageGS115Not in Commercial Distribution
15099169676746PackageGS115Not in Commercial Distribution
15099169676753PackageGS115Not in Commercial Distribution
15099169676760PackageGS115Not in Commercial Distribution
15099169676777PackageGS115In Commercial Distribution
15099169676814PackageGS115In Commercial Distribution
15099169676821PackageGS115Not in Commercial Distribution
15099169676852PackageGS115In Commercial Distribution
15099169676890PackageGS115In Commercial Distribution
65099169686740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05099169706019050991697060195099169706019
05099169706026050991697060265099169706026
05099169706040050991697060405099169706040
05099169706057050991697060575099169706057
05099169706064050991697060645099169706064
05099169706071050991697060715099169706071
05099169706118050991697061185099169706118
05099169706125050991697061255099169706125
05099169706156050991697061565099169706156
05099169706194050991697061945099169706194
1509916967671515099169676715
1509916967672215099169676722
1509916967674615099169676746
1509916967675315099169676753
1509916967676015099169676760
1509916967677715099169676777
1509916967681415099169676814
1509916967682115099169676821
1509916967685215099169676852
1509916967689015099169676890
6509916968674065099169686740

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
Lot or batch
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

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