ETEKCITY Arm Blood Pressure Monitor

GUDID 06953775650342

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953775650342
NIH Device Record Key539cb48f-18e5-4317-9f5a-33f5d1e29648
Commercial Distribution StatusIn Commercial Distribution
Brand NameETEKCITY Arm Blood Pressure Monitor
Version Model NumberAES-U631-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 Numberfalse
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
GS106953775650342 [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 Date2019-05-08

On-Brand Devices [ETEKCITY Arm Blood Pressure Monitor]

06953775650342AES-U631-A
06953775650335AES-U522-A

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