FDA.reportPublic FDA data

Alcedo

Primary DI
00856471007082
Brand
Alcedo
Company
NATURE MAJOR INC
Model
AE169
Device description
Upper Arm Blood Pressure Monitor
Published
2019-07-16
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
10856471007089PackageGS110In Commercial Distribution
00856471007082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085647100708910856471007089
00856471007082008564710070828564710070820856471007082

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.

Regulatory Flags#

DUNS number
114908257
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856471007112AlcedoAE1702019-06-24
00856471007211AlcedoAE1752020-06-23
00856471007266AlcedoAE1802021-11-04
00856471007280AlcedoAE1822021-11-04
00856471007303AlcedoAE1832021-11-04
00856471007235AlcedoAE1772020-07-30
00856471007310AlcedoB212021-11-04
00856471007327AlcedoAE1762021-11-04
10856471007263AlcedoAE1802021-11-04
10856471007287AlcedoAE1822021-11-04
10856471007300AlcedoAE1832021-11-04
10856471007317AlcedoB212021-11-04
10856471007324AlcedoAE1762021-11-04
00856471007204AlcedoAE1742020-04-06
00856471007174AlcedoAE1712019-10-22
20856471007239AlcedoAE1772020-07-30
10856471007218AlcedoAE1752020-06-23
10856471007201AlcedoAE1742020-04-06
00856471007099AlcedoB212019-04-09
10856471007089AlcedoAE1692019-07-16

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Primary DI, Brand, Company table
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04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
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06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
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