FDA.reportPublic FDA data

Hy-Vee Health Wireless BPM

Primary DI
00075450227420
Brand
Hy-Vee Health Wireless BPM
Company
HY-VEE, INC.
Model
UA-651BLE-HV
Catalog number
UA-651BLE-HV
Device description
Digital Blood Pressure Monitor
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00075450227420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075450227420000754502274200754502274200075450227420

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006925671
Device count
1
Serial number
true

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00075450825657hyvee 0754508256572026-01-05
00075450825916hyvee0754508259162026-01-05
00075450826012hyvee 0754508260122026-01-05
00075450841398hyvee0754508413982026-01-05
00075450841442hyvee 0754508414422026-01-05
20075450825569hyvee0754508255652026-01-05
20075450825576hyvee0754508255722026-01-05
20075450825651hyvee 0754508256572026-01-05
20075450825910hyvee0754508259162026-01-05
20075450826016hyvee 0754508260122026-01-05
60075450841390hyvee0754508413982026-01-05
20075450841446hyvee 0754508414422026-01-05
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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