FDA.reportPublic FDA data

PowerCube+ Series

Primary DI
07613365501247
Brand
PowerCube+ Series
Company
Ganshorn Medizin Electronic GmbH
Model
A
Device description
The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber.
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic
JEHPlethysmograph, Volume

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2
JEHPlethysmograph, VolumeAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365501247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365501247076133655012477613365501247

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
318498177
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613365500400PowerCube+ SeriesA2024-12-20
07613365501193PowerCube+ SeriesA2025-03-31
07613365501209PowerCube+ SeriesA2025-03-31
07613365501216PowerCube+ SeriesA2025-03-31
07613365501223PowerCube+ SeriesA2025-03-31
07613365501230PowerCube+ Series A2025-03-31
07613365501254PowerCube+ SeriesA2025-03-31
07613365500301PowerCube+ SeriesA2024-12-20
07613365500431PowerCube+ Series A2024-12-20
07613365501018PowerCube+ SeriesA2024-12-20
07613365501032PowerCube+ SeriesA2024-12-20
07613365501070PowerCube+ SeriesA2024-12-20
07613365501094PowerCube+ SeriesA2024-12-20
07613365500127SpiroDefA2024-12-20
07613365500141SpiroDefA2024-12-20
07613365500202SpiroDefA2024-12-20
07613365500110SpiroDefA2024-12-20
07613365500134SpiroDefA2024-12-20
07613365500196SpiroDefA2024-12-20
07613365500011SpiroScoutF0134005012023-07-03

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Primary DI, Brand, Company table
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08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320363MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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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
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07613365501209PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501216PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20