FDA.reportPublic FDA data

MediBio TD-3140 Blood Pressure Monitor

Primary DI
00850014981006
Brand
MediBio TD-3140 Blood Pressure Monitor
Company
MEDIBIO USA LLC
Model
TD-3140
Published
2020-01-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014981006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014981006008500149810068500149810060850014981006

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
012481654
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014981051Medibio TD-4277 Blood Glucose Test Strips 50pcsTD-42772020-01-24
00850014981020MediBio TD-8255 Fingertip Pulse OximeterTD-82552020-01-23
00850014981013Medibio TD-4277 Blood Glucose Monitoring SystemTD-42772020-01-23
00850014981037MediBio TD-2555 Weight ScaleTD-25552020-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
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00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27