FDA.reportPublic FDA data

COSMED

Primary DI
18052400180355
Brand
COSMED
Company
C O S M E D SRL
Model
Q-Box
Device description
The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120146000QUARK SERIESCosmed Srl2012-12-11CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052400180355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018035518052400180355

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

Contacts#

Phone, Email table
PhoneEmail
+39069315492support@cosmed.it

Regulatory Flags#

DUNS number
438896136
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18052400180522COSMEDQ-NRG2020-02-13
18052400180539COSMEDQ-NRG+2020-02-13
18052400180171COSMEDQuark RMR2016-09-23
18052400180201COSMEDFitmate2016-09-23
18052400180362COSMEDFitmate GS2016-09-23
18052400180034COSMEDmicroQuark2016-09-23
18052400180041COSMEDPony FX2016-09-23
18052400180058COSMEDPony FX Flowsafe2016-09-23
18052400180065COSMEDQuark SPIRO2016-09-23
18052400180072COSMEDSpiropalm2016-09-23
18052400180096COSMEDSpiropalm 6MWT2016-09-23
18052400180379COSMEDPony FX MIP/MEP2016-09-23
18052400180126COSMEDK4b22016-09-23
18052400180157COSMEDK4b22016-09-23
18052400180164COSMEDQuark PFT2016-09-23
18052400180188COSMEDQuark CPET2016-09-23
18052400180225COSMEDFitmate Pro2016-09-23
18052400180249COSMEDFitmate Med2016-09-23
18052400180263COSMEDQuark C12x2016-09-23
18052400180287COSMEDQuark T12x2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050991693321579100 VITALOGRAPH VitaloLAB+VITALOGRAPH (IRELAND) LIMITEDBTY2026-06-02
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
14250892909117JaegerJaeger Medical GmbHBTY2025-08-11
14250892907670JaegerJaeger Medical GmbHBTY2025-07-29
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08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20