FDA.reportPublic FDA data

Omada

Primary DI
B726BT104O0
Brand
Omada
Company
BODYTRACE, INC
Model
BT104O
Device description
Upper arm blood pressure monitor.
Published
2019-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B726BT104O1PackageHIBCC1In Commercial Distribution
B726BT104O2PackageHIBCC5In Commercial Distribution
B726BT104O0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
116841525
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B726BT007A0BodyTraceBT007A2025-03-14
B726BT007B0BodyTraceBT007B2025-03-14
B726BT007A1BodyTraceBT007A2025-03-14
B726BT007B1BodyTraceBT007B2025-03-14
B726BT0060BodyTraceBT0062021-11-03
B726BT1060BodyTraceBT1062021-11-03
B726BT0061BodyTraceBT0062021-11-03
B726BT1061BodyTraceBT1062021-11-03
B726BT0050BodyTraceBT0052020-07-06
B726BT005O0OmadaBT0052020-07-06
B726BT005V0VidaBT0052020-07-06
B726BT0051BodyTraceBT0052020-07-06
B726BT005O1OmadaBT0052020-07-06
B726BT005V1VidaBT0052020-07-06
B726BT1050BodyTraceBT1052020-06-23
B726BT105O0OmadaBT105O2020-06-23
B726BT1051BodyTraceBT1052020-06-23
B726BT105O1OmadaBT105O2020-06-23
B726BT1040BodyTraceBT1042019-04-01
B726BT1042BodyTraceBT1042019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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