FDA.reportPublic FDA data

Arm Type Automatic Blood Pressure Monitor

Primary DI
06953205900375
Brand
Arm Type Automatic Blood Pressure Monitor
Company
Shenzhen Jiacom Technology Co., Ltd
Model
BP396A
Published
2018-07-03
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
K172896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172896000Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312Shenzhen Jiacom Technology CO ., Ltd.2018-01-26DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06953205900375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06953205900375069532059003756953205900375

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
421098256
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953205995043Infrared ThermometerFR8002026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorBP367A2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorBP313A2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorBP351A2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorBP362A2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorBP366A2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorBP369A2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorBP380A2026-03-20
06953205995142Arm Type Automatic Blood Pressure MonitorBP389A2026-03-20
06953205900870Infrared ThermometerFR8202020-10-28
06953205900887Infrared ThermometerFR8102020-10-28
06953205900788Infrared ThermometerIFR6002018-07-03
06953205900795Infrared ThermometerIFR6102018-07-03
06953205900801Infrared ThermometerIFR6602018-07-03
06953205900818Infrared ThermometerFR8002018-07-23
06953205900825Infrared ThermometerFR8302018-07-23
06953205900832Infrared ThermometerFR8402018-07-23
06953205900849Infrared ThermometerFR8502018-07-23
06953205900856Infrared ThermometerFR8702018-07-23
06953205900863Infrared ThermometerFR8802018-07-23

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Primary DI, Brand, Company table
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