FDA.reportPublic FDA data

COSMED

Primary DI
18052400180201
Brand
COSMED
Company
C O S M E D SRL
Model
Fitmate
Device description
The device is intended for use in clinical and research application to measure oxygen uptake. Fitmate is designed for the measurement of Resting Metabolic Rate only.
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
BZLComputer, Oxygen-Uptake

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZLComputer, Oxygen-UptakeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071533000FITMATE SERIESCosmed Srl2007-09-28BZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052400180201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018020118052400180201

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

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
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZL2026-04-15
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00810445030001MicrolifeMICROLIFE USA, INC.BZL2023-06-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZL2023-04-19
00195278524089NAGE Healthcare Finland OyBZL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZL2022-05-13
00840682104135NAGE Healthcare Finland OyBZL2022-03-07
00840682104302NAGE Healthcare Finland OyBZL2022-03-07
B6568100ReeVueKORR MEDICAL TECHNOLOGIES INC.BZL2022-03-03
B9671503000MOXUSAei Technologies, Inc.BZL2021-11-03
B9671504000MAXIIAei Technologies, Inc.BZL2021-11-03
00840682143806CARESCAPE B650GE Healthcare Finland OyBZL2020-03-11
00840682142380CARESCAPE B450GE Healthcare Finland OyBZL2020-03-09
00840682123433CARESCAPE RADGE Healthcare Finland OyBZL2020-03-05
00840682144308CARESCAPE B850GE Healthcare Finland OyBZL2020-03-05
00840682138147NAGE Healthcare Finland OyBZL2019-06-19
00840682138161NAGE Healthcare Finland OyBZL2019-06-19
00860001261509MediPines Gas Exchange MonitorMEDIPINES CORPORATIONBZL2019-03-25
00860001261516MediPines Single Patient Use Breathing CircuitMEDIPINES CORPORATIONBZL2019-03-25
00860001261530MediPines Gas Exchange Monitor Starter KitMEDIPINES CORPORATIONBZL2019-03-25
00810016250012MCG DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-23
00810016250111MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-23
00810016250081MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250159MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250005MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250029MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250036MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22