FDA.reportPublic FDA data

COSMED

Primary DI
18052400180362
Brand
COSMED
Company
C O S M E D SRL
Model
Fitmate GS
Device description
This device is intended for use in clinical and research application to measure oxygen uptake.
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
18052400180362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018036218052400180362

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
18052400180201COSMEDFitmate2016-09-23
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
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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
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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