FDA.reportPublic FDA data

AC Adapter for HEM-907XL

Primary DI
00073796149079
Brand
AC Adapter for HEM-907XL
Company
Omron Healthcare, Inc.
Model
HEM-ADPT907
Catalog number
HEM-ADPT907
Device description
AC Adapter for HEM-907XL, Digital Blood Pressure Monitor
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032305000OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XLOmron Healthcare, Inc.2004-02-11DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796149076PackageGS120In Commercial Distribution
20073796149073PackageGS12In Commercial Distribution
00073796149079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379614907610073796149076
2007379614907320073796149073
00073796149079000737961490790737961490790073796149079

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supplyA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-4350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
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
00073796736538Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
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
00073796330132AC Adapter for NE-C30C30AC2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27