MOCACuff

GUDID 00850842006063

MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch. The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.

MOCACARE CORP.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00850842006063
NIH Device Record Key229cf2cc-66a1-4fc5-928d-db69c918b0f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOCACuff
Version Model NumberWhite (HL168KF)
Company DUNS079824513
Company NameMOCACARE CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850842006063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-11-29

On-Brand Devices [MOCACuff]

00850842006063MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic
00850842006056HL168KF

Trademark Results [MOCACuff]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MOCACUFF
MOCACUFF
87940196 5648777 Live/Registered
MOCACARE Corp
2018-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.