FDA.reportPublic FDA data

Microlife

Primary DI
00810445030001
Brand
Microlife
Company
MICROLIFE USA, INC.
Model
MedGem
Device description
MedGem is an indirect calorimeter, which is intended to measure oxygen uptake for measurement of patient resting metabolic rate (RMR).
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZLComputer, Oxygen-Uptake

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810445030001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810445030001008104450300018104450300010810445030001

GMDN Terms#

Term, Definition table
TermDefinition
Indirect calorimeterAn electrically-powered device primarily intended to measure oxygen consumption (VO2) and/or carbon dioxide output (VCO2) to estimate resting energy expenditure (REE) and/or resting metabolic rate (RMR), typically for weight loss/maintenance and nutritional assessments. It is intended to be used with a face mask, mouthpiece and/or head hood into which the patient breathes, and includes a display, controls, and connection ports. It is used in healthcare or research settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176387785
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719003406516MicrolifeFR1MZ1-B2026-01-31
14719003406513MicrolifeFR1MZ1-B2026-01-31
00642632472000MicrolifeNEB2002020-05-13
00642632900251microlifeBPHJE2-D2025-03-21
10642632900258microlifeBPHJE2-D2025-03-21
04719003315085MicrolifeCRO-BP3MX1-3C12025-03-11
06970388169511MicrolifeCuff-L-WBPA2025-02-10
16970388169518MicrolifeCuff-L-WBPA2025-02-10
04719003315030MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
04719003315047MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
14719003315037MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
14719003315044MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
04719003631284MicrolifeBP3SZ1-1AFIB2024-10-28
06970388169160MicrolifeBP3MX1-32024-10-28
06970388169221MicrolifeCuff-LXL-WBPH2024-10-28
06970388169429MicrolifeCuff-L-WBPH2024-10-28
06970388169528MicrolifeCuff-LXL-WBPA2024-10-28
14719003631281MicrolifeBP3SZ1-1AFIB2024-10-28
16970388169167MicrolifeBP3MX1-32024-10-28
16970388169228MicrolifeCuff-LXL-WBPH2024-10-28

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Primary DI, Brand, Company table
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B9671504140MAXIIaAei Technologies, Inc.BZL2025-01-27
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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
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00810016250029MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250036MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250043MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22