FDA.reportPublic FDA data

COSMED

Primary DI
18052400180539
Brand
COSMED
Company
C O S M E D SRL
Model
Q-NRG+
Published
2020-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190800000Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl2020-02-06BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052400180539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018053918052400180539

GMDN Terms#

Term, Definition table
TermDefinition
Indirect calorimeter, line-poweredA mains electricity (AC-powered) device intended to be used clinically to measure oxygen consumption (VO2) to estimate the resting metabolic rate (RMR) of a patient. It typically includes a mouthpiece with a unidirectional breathing valve into which the patient breathes, displays for direct read out, and connections for transfer of data to a computer for further analysis. It may be used in a wide variety of healthcare or research settings to obtain accurate measurements used in weight management, nutritional, or other medically-supervised programs.

Sterilization Methods#

Method table
Method

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
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
18052400180355COSMEDQ-Box2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050991693321579100 VITALOGRAPH VitaloLAB+VITALOGRAPH (IRELAND) LIMITEDBTY2026-06-02
00850000967328SpiroLoopCMI HEALTH INC.BTY2026-03-06
00850000967625SpiroLink 2 ProCMI HEALTH INC.BTY2026-03-06
04250892908816JaegerJaeger Medical GmbHBTY2025-11-24
04250892908861JaegerJaeger Medical GmbHBTY2025-11-24
04250892909059JaegerJaeger Medical GmbHBTY2025-11-24
04250892909066JaegerJaeger Medical GmbHBTY2025-11-24
34250892908633JaegerJaeger Medical GmbHBTY2025-10-31
04250892908304JaegerJaeger Medical GmbHBTY2025-10-31
04250892908311JaegerJaeger Medical GmbHBTY2025-10-31
04250892908328JaegerJaeger Medical GmbHBTY2025-10-31
04250892908618JaegerJaeger Medical GmbHBTY2025-10-31
34250892908213JaegerJaeger Medical GmbHBTY2025-08-18
04057155000948ERT PTeResearchTechnology GmbHBTY2025-08-11
04057155000955ERT PTeResearchTechnology GmbHBTY2025-08-11
14250892909117JaegerJaeger Medical GmbHBTY2025-08-11
14250892907670JaegerJaeger Medical GmbHBTY2025-07-29
14250892907687JaegerJaeger Medical GmbHBTY2025-07-29
14250892907694JaegerJaeger Medical GmbHBTY2025-07-29
14250892907700JaegerJaeger Medical GmbHBTY2025-07-29
14250892907748JaegerJaeger Medical GmbHBTY2025-07-29
14250892907755JaegerJaeger Medical GmbHBTY2025-07-29
14250892907571JaegerJaeger Medical GmbHBTY2025-07-24
14250892907526JaegerJaeger Medical GmbHBTY2025-07-23
14250892907533JaegerJaeger Medical GmbHBTY2025-07-23
14250892907557JaegerJaeger Medical GmbHBTY2025-07-23
14250892907564JaegerJaeger Medical GmbHBTY2025-07-23
14250892907588JaegerJaeger Medical GmbHBTY2025-07-23
14250892907595JaegerJaeger Medical GmbHBTY2025-07-23
14250892907601JaegerJaeger Medical GmbHBTY2025-07-23