FDA.reportPublic FDA data

PARAMED

Primary DI
00856324008693
Brand
PARAMED
Company
SILEX GLOBAL LLC
Model
Digital Blood Pressure Monitor (Upper-arm) B22
Device description
Is a digital device used to measure blood pressure (Upper-arm)
Published
2021-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K200437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200437000Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd.2020-06-25DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856324008693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856324008693008563240086938563240086930856324008693

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
081135914
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856324008778PARAMEDB222026-08-22
00856324008112ParamedRH30092022-12-23
00856324008129ParamedRH30122022-12-23
00856324008440ParamedCM-41362022-12-23
00856324008136ParamedThermometer DT0012018-05-18
00856324008723PARAMEDDigital Blood Pressure Monitor (Upper-arm) B152021-10-28
00856324008730PARAMEDDigital Blood Pressure Monitor (Upper-arm) B22S2021-10-28
00856324008181paramedInfrared ear/forehead thermometer YK-IRT12020-06-19
00856324008297paramedInfrared ear/forehead thermometer PG-IRT16032020-06-19
00856324008488paramedWrist Blood Pressure monitor PG-800A372020-06-19
00856324008310PARAMEDPG-800A112019-09-02
00856324008426PARAMEDB512019-09-02
00856324008099ParamedDigital Blood Pressure Monitor (Upper-arm) B222018-05-18
00856324008105ParamedWrist Blood Pressure monitor PG-800A122018-05-18
00856324008327PARAMEDMAX0201 2019-06-14
00856324008334PARAMEDMAX0201 2019-06-14
00856324008341PARAMEDMAX0201 2019-06-14
00856324008358PARAMEDMAX022019-06-14
00856324008365PARAMEDMAX022019-06-14
00856324008372PARAMEDMAX022019-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01