FDA.reportPublic FDA data

Homedics

Primary DI
04719872483502
Brand
Homedics
Company
HEALTH & LIFE CO., LTD.
Model
1565256A-6SH/ BPA-960BTA-WT
Device description
Arm type blood pressure monitor
Published
2025-03-27
Public version status
New
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
04719872483502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872483502047198724835024719872483502

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 Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657836743
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872489238Hello HeartHHBPA-CUFFXL2025-12-04
04719872483571HomedicsBPA-945B2025-06-10
04719872483496Hello HeartHHBPA-100BT2025-04-18
04719872480013WalgreensWGNBPW-9102016-06-13
04719872480020WalgreensWGNBPW-9202016-06-13
04719872480167WRISTECH82-36492016-08-11
04719872480181WRISTECH ZB-3649 2016-08-17
04719872480204HoMedicsBPW-O2002018-06-22
04719872483014WalgreensWGNBPA-9402016-06-13
04719872483021WalgreensWGNBPA-9502016-06-13
04719872483038WalgreensWGNBPA-960BT2016-06-13
04719872483205WalgreensWGNBPA-9452017-10-30
04719872483229HoMedicsBPA-O2002018-06-22
04719872483236HoMedicsBPA-0652019-04-01
04719872483243PRESTIGEHM-30-OB2019-02-27
04719872483250 PRESTIGEHM-352019-02-27
04719872483267Prime AlertPA0012019-02-27
04719872483274HM01WMTBPA-240BT2021-08-02
04719872486022Clinical GuardHL1002016-11-03
04719872486039eMistEM100A 2017-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
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
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012257AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012301AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012318AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012325AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012332AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012349AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012356AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012363AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012370AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09