FDA.reportPublic FDA data

LotFancy

Primary DI
04710953420768
Brand
LotFancy
Company
LOTFANCY INC.
Model
11C-1863-Q
Device description
Wrist Type Blood Pressure Monitor BP11
Published
2016-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710953420768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710953420768047109534207684710953420768

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive blood pressure simulatorAn instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009651371
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16970384256793LotFancy11C-1879-G2017-02-16
16970384257790LotFancy11C-1880-H2017-02-16
10697038425119LotFancy11C-1899-A2016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27