FDA.reportPublic FDA data

VitaloQUB

Primary DI
05099169916104
Brand
VitaloQUB
Company
VITALOGRAPH (IRELAND) LIMITED
Model
9160
Device description
9160 VITALOGRAPH VitaloQUB - EN
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEHPLETHYSMOGRAPH, VOLUME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEHPlethysmograph, VolumeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223818000Model 9160 VitaloQUBVitalograph Ireland, Ltd.2023-05-25JEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05099169916104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05099169916104050991699161045099169916104

GMDN Terms#

Term, Definition table
TermDefinition
Whole-body plethysmographA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

Sterilization Methods#

Method table
Method

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
04250892908731JaegerJaeger Medical GmbHJEH2025-11-24
04250892908816JaegerJaeger Medical GmbHJEH2025-11-24
04250892908861JaegerJaeger Medical GmbHJEH2025-11-24
04250892908304JaegerJaeger Medical GmbHJEH2025-10-31
04250892908311JaegerJaeger Medical GmbHJEH2025-10-31
04250892908328JaegerJaeger Medical GmbHJEH2025-10-31
14250892909117JaegerJaeger Medical GmbHJEH2025-08-11
07613365501193PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365501209PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365501216PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHJEH2025-03-31
07613365501247PowerCube+ Series Ganshorn Medizin Electronic GmbHJEH2025-03-31
07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365500400PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365500431PowerCube+ Series Ganshorn Medizin Electronic GmbHJEH2024-12-20
07613365501018PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365501032PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365501070PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
07613365501094PowerCube+ SeriesGanshorn Medizin Electronic GmbHJEH2024-12-20
14250892903726VyaireJaeger Medical GmbHJEH2021-04-01
14250892903900VyaireJaeger Medical GmbHJEH2021-04-01
14250892903917VyaireJaeger Medical GmbHJEH2021-04-01
04250892905693VyaireJaeger Medical GmbHJEH2021-01-21
14250892905799VyaireJaeger Medical GmbHJEH2021-01-21
04250892904672VyaireJaeger Medical GmbHJEH2019-10-14
04250892904689VyaireJaeger Medical GmbHJEH2019-10-14
00817065022478HokansonD.E.HOKANSON, INC.JEH2018-03-01
00817065021440HokansonD.E.HOKANSON, INC.JEH2016-09-23