FDA.reportPublic FDA data

Blood Pressure Monitor

Primary DI
00073796736538
Brand
Blood Pressure Monitor
Company
Omron Healthcare, Inc.
Model
BP7365CAN-CD6
Catalog number
BP7365CAN-CD6
Device description
Upper Arm Blood Pressure Monitor with Possible AFib Detection Feature, 60 memory per user, 2 user total, Automatic Inflation, AC Adapter, Hypertension Indicator
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification FeatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230076000Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))Omron Healthcare, Inc.2024-10-08QXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796736535PackageGS16In Commercial Distribution
00073796736538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379673653510073796736535
00073796736538000737967365380737967365380073796736538

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 Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-634-4350quality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073796252601Silver, Upper Arm Blood Pressure MonitorBP52602026-05-26
00073796451004Omron MicroAir Vibrating Mesh NebulizerNE-U100NE-U1002018-10-22
00073796800147Omron CompAir Compressor NebulizerRE-C800KDRE-C800KD2020-08-03
00073796451226Omron Micro Air Vibrating Mesh NebulizerNE-U22VNE-U22V2017-05-17
00073796453305Omron CompAir Elite Compact Compressor NebulizerNE-C30NE-C302017-05-17
00073796458010Omron CompAir Compressor NebulizerNE-C801NE-C8012017-05-17
00073796458034Omron CompAir Mini-NebulizerNE-C803NE-C8032017-05-17
00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
10073796760066Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
10073796736535Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
00073796343927Omron Small D-ring CuffHEM-CS24-BHEM-CS24-B2019-04-03
00073796725310Omron 5 Series Upper Arm Blood Pressure MonitorBP7250CANBP7250CAN2019-07-08
00073796735319Omron 7 Series Upper Arm Blood Pressure MonitorBP7350CANBP7350CAN2019-07-08
00073796745318Omron 10 Series Upper Arm Blood Pressure MonitorBP7450CANBP7450CAN2019-07-08
00073796893101Blood Pressure Monitor BP9310TBP9310T2022-07-01
00073796745530Omron Blood Pressure MonitorBP7455CAN-CD6BP7455CAN-CD62021-09-01
00073796100315Omron 3 Series Upper Arm Blood Pressure MonitorBP7100CANBP7100CAN2019-07-08
00073796146054AC Adapter for digital Blood Pressure UnitsHEM-ADPTW5HEM-ADPTW52016-09-16
00073796149079AC Adapter for HEM-907XLHEM-ADPT907HEM-ADPT9072016-09-16
00073796330132AC Adapter for NE-C30C30AC2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073796252601Silver, Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.QXY2026-05-26
10073796736535Blood Pressure MonitorOmron Healthcare, Inc.QXY2025-06-27
00073796253608Gold Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
10073796253605Gold Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
00073796254650Platinum Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
000737962736067 Series Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.QXY2024-12-31
0007379627465810 Series Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.QXY2024-12-31