FDA.reportPublic FDA data

Choice Basic Wrist Blood Pressure Monitor

Primary DI
00860418002672
Brand
Choice Basic Wrist Blood Pressure Monitor
Company
ARCADIA GROUP
Model
UB-543-CP
Catalog number
UB-543-CP
Device description
Digital Wrist Blood Pressure Monitor.
Published
2018-12-06
Public version status
Update
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

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
00860418002672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860418002672008604180026728604180026720860418002672

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555630941
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860418002658Choice Basic Blood Pressure MonitorUA-611-CP2018-12-06
00860418002665Choice Basic Blood Pressure Monitor, Multi-UserUA-767F-CPUA-767F-CP2018-12-06
00860418002689Choice Wireless Upper Arm Blood Pressure MonitorUA-651BLE-CPUA-651BLE-CP2018-12-06
10860418002600Choice8000-106342018-09-07
10860418002617Choice8000-106352018-09-07
10860418002624Choice8000-106302018-09-07
00860418002603Choice8000-106342018-09-07
00860418002610Choice8000-106352018-09-07
20860418002607Choice8000-106342018-09-07
20860418002614Choice8000-106352018-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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