Owlhealth Arm Blood Pressure Monitor

GUDID 06953775621229

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953775621229
NIH Device Record Keyf757437a-b239-4be6-861b-7030f6eede6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOwlhealth Arm Blood Pressure Monitor
Version Model NumberAES-U111-E
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
GS106953775621229 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-23
Device Publish Date2022-11-15

Devices Manufactured by Alicn Medical Shenzhen, Inc.

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06953775633345 - BBLOVE Arm Blood Pressure Monitor2024-07-30
06953775660297 - ERDPAA Arm Blood Pressure Monitor2024-07-15
06953775660105 - ERDPAA Arm Blood Pressure Monitor2024-04-19
06953775660112 - BBLOVE Arm Blood Pressure Monitor2024-04-19

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