FDA.reportPublic FDA data

Blood Pressure Monitor LC-BP01

Primary DI
34897118930018
Brand
Blood Pressure Monitor LC-BP01
Company
APEMAN INTERNATIONAL CO., LIMITED
Model
22~42
Device description
Upper Arm Type Intelligent Blood Pressure Monitor (comes with Cuff of 22~42cm)
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34897118930018PackageGS115In Commercial Distribution
04897118930017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3489711893001834897118930018
04897118930017048971189300174897118930017

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
664454552
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897118930017Blood Pressure Monitor LC-BP0122~422021-03-30
04897118930024Blood Pressure Monitor LC-BP0122~322021-03-30
34897118930025Blood Pressure Monitor LC-BP0122~322021-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413405657ABPMpro SoftwareSOMNOmedics AGDXN2026-10-07
10884450480615Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2026-10-07
00634782102357ADView® 2.6AMERICAN DIAGNOSTIC CORPDXN2026-10-06
00198953009567Carescape ONEGE Healthcare Finland OyDXN2026-10-04
00810226060166Easy@Home Blood Pressure MonitorEASY HEALTHCARE CORPORATIONDXN2026-09-30
06948423816218Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.DXN2026-09-30
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
06953825911850sakerplusShenzhen Urion Technology Co., LtdDXN2026-09-18
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18