FDA.reportPublic FDA data

Spirolyser

Primary DI
03760253450003
Brand
Spirolyser
Company
FIM MEDICAL
Model
Q13
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161676000Q13 SPIROLYSER®Fim Medical2016-10-20BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760253450003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760253450003037602534500033760253450003

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].

Contacts#

Phone, Email table
PhoneEmail
+33(0)472343031joanna.corre@depisteo.com

Regulatory Flags#

DUNS number
577219207
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760253450638ErgofilterSP12023-09-04
03760253450645ErgofilterSP1M2023-09-04
03760253450614SPIROWINExpert2023-07-05
03760253450621SPIROWIN EXPERT DEPISTEO2023-07-05
03760253450263PipettePipette2017-09-15
03760253450577VT1Software 2022-06-07
03760253450157VT1Software2017-10-17
03760253450249VT1ESSENTIAL EDITION2017-10-16
03760253450607SPIROWIN EXPERT DEPISTEO2022-03-16
03760253450010Spirowin Expert2017-05-04
03760253450447VT1 Junior SHVT1 Junior SH FF10852021-11-30
03760253450454VT1 US FAAVT1 FAA FF10842021-11-30
03760253450461Face cover for Visiolite/VT1FF10862021-11-30
03760253450522Q13 DEPISTEO SpirolyserFF1153 Q13 Depisteo2021-11-30
03760253450546VT1 DMV-BDMV-B2021-11-30
03760253450553VT1 DMV-CDMV-C2021-11-30
03760253450560VT1 DMV-DDMV-D2021-11-30
03760253450195QFLOWQFLOW2017-05-04
03760253450270NOSE CLIPNOSE CLIP2017-10-15
03760253450287TRAPPERTRAPPER2017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613365501216PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
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
07613365500400PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20
07613365500431PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2024-12-20