FDA.reportPublic FDA data

blood pressure monitor

Primary DI
00817746020007
Brand
blood pressure monitor
Company
BETTER BASICS, INC.
Model
MP-BPM20A-US
Published
2016-11-18
Public version status
Update
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
K101681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101681000TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd.2011-05-27DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817746020014PackageGS11In Commercial Distribution
00817746020021PackageGS112In Commercial Distribution
00817746020007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817746020014008177460200148177460200140817746020014
00817746020021008177460200218177460200210817746020021
00817746020007008177460200078177460200070817746020007

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
013029698
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817746020366Pulse MassagerMP-TENS-1102016-11-18
00817746020397Pulse MassagerMP-TENS310-US2016-11-18
00817746020915Pulse MassagerMP-TENS510-US2017-05-26
00817746021226Pulse OximeterMP-OX3002017-09-15
00817746020151Pulse oximeterMP-OX150-US2016-11-18
00817746020182Pulse oximeterMP-OX200-US2016-11-18
00817746020212Pulse oximeterMP-OX250-US2016-11-18
00817746026665Fever ThermometerMP-IRT4502017-09-15
00817746020243Fever therometerMP-TM21-US2016-11-18
00817746020274Fever therometerMP-IRT350-US2016-11-18
00817746020038blood pressure monitorMP-BPM50W-US2016-11-18
00817746020069blood pressure monitorMP-BPMW60-US2016-11-18
00817746020090blood pressure monitorMP-BPMA70-US2016-11-18
00817746020120blood pressure monitor MP-BPM80A-US2016-11-18
00817746020304Body fat scaleSW-SBS5002016-11-18
00817746021233Pulse OximeterMP-OX3002017-09-15
00817746021325Fever ThermometerMP-IRT4502017-09-15
00817746020335Body fat scaleSW-SBS7002017-01-17
00817746020342Body fat scaleSW-SBS7002017-01-17

Other Devices Sharing Product Codes#

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
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00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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