FDA.reportPublic FDA data

MARNUR Blood Pressure Monitor

Primary DI
06971508420000
Brand
MARNUR Blood Pressure Monitor
Company
Shenzhenshi Dingqian E-Commerce Co.,Ltd.
Model
TMB-1583
Device description
The MARNUR Blood Pressure Monitor TMB-1583 is digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm (about 8¾˝-16½˝).It is intended for adult indoor use only.
Published
2018-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K120058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120058000TRANSTEK BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.2012-01-31DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36971508420001PackageGS110In Commercial Distribution
06971508420000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697150842000136971508420001
06971508420000069715084200006971508420000

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height118Millimeter
Length107Millimeter
Weight250Gram
Width103Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999support@marnuronline.com

Regulatory Flags#

DUNS number
544580789
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
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00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27