FDA.reportPublic FDA data

A&D Medical

Primary DI
00093764603358
Brand
A&D Medical
Company
A&D COMPANY, LIMITED
Model
UB-543
Catalog number
UB-543
Device description
Digital Wrist Blood Pressure Monitor.
Published
2016-09-23
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
K141179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141179000A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITORA & D Co., Ltd.2014-06-27DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00093764603358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00093764603358000937646033580937646033580093764603358

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-726-9966htn@andonline.com

Regulatory Flags#

DUNS number
691722987
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00093764604737A&D MedicalUA-652BLEUA-652BLE2026-09-25
00093764604744A&D MedicalUA-606UA-6062026-09-25
00093764604720A&D MedicalUA-1020CEL-CSUA-1020CEL-CS2026-05-08
00093764604553A&D MedicalUA-660CNUA-660CN2026-02-27
00093764604522A&D MedicalUA-810BLEUA-810BLE2025-02-19
00093764604539A&D MedicalUA-910BLEUA-910BLE2025-02-19
00093764604447A&D MedicalUA-1020CELUA-1020CEL2024-12-10
00093764604140A&D MedicalUC-356BLEUC-356BLE2024-10-18
00093764604546A&D MedicalUC-356BLE-STUC-356BLE-ST2024-10-18
00093764604454A&D MedicalUC-352CELUC-352CEL2024-10-16
00093764604492A&D MedicalUA-660UA-6602024-09-01
00093764604508A&D MedicalUA-770BLEUA-770BLE2024-09-01
00093764604515A&D MedicalUA-1040TBLEUA-1040TBLE2024-09-01
00093764604461A&D MedicalUC-450BLE-CVUC-450BLE-CV & UC-450BLE2024-01-01
00093764603501A&D MedicalTM-2657PTM-2657P, TM-2657P-RS, TM-2657P-BT2016-09-23
00093764604133A&D MedicalUP-200UP-2002024-02-15
00093764600623A&D MedicalUA-789UA-789AC2016-09-23
00093764601576A&D MedicalUA-705UA-705V2016-09-23
00093764601583A&D MedicalUA-705UA-705VL2016-09-23
00093764602870A&D MedicalUA-1020UA-10202016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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