Sinocare Arm Blood Pressure Monitor

GUDID 06953775658256

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953775658256
NIH Device Record Keyd8f36325-55b0-4fd9-b36b-289e3890ef70
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinocare Arm Blood Pressure Monitor
Version Model NumberAES-U131-A
Company DUNS548040741
Company NameAlicn Medical Shenzhen, Inc.
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106953775658256 [Primary]
GS106953775658256 [Primary]
GS106953775658256 [Primary]
GS106953775658256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Sinocare Arm Blood Pressure Monitor]

06953775658256AES-U131-A
06953775658232black
06953775658225white

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.