FDA.reportPublic FDA data

A&D Medical

Primary DI
00093764604492
Brand
A&D Medical
Company
A&D COMPANY, LIMITED
Model
UA-660
Catalog number
UA-660
Device description
Upper Arm Blood Pressure Monitor.
Published
2024-09-01
Public version status
New
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
K141160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141160000A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITORA & D Co., Ltd.2014-10-07DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00093764604492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00093764604492000937646044920937646044920093764604492

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
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
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
00093764602931A&D MedicalUA-1030TUA-1030T2016-09-23
00093764603341A&D MedicalUA-651UA-6512016-09-23
00093764603358A&D MedicalUB-543UB-5432016-09-23

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Primary DI, Brand, Company table
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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
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06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
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06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
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