FOND Arm Blood Pressure Monitor

GUDID 06953775650120

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953775650120
NIH Device Record Key92440476-5db7-460b-a6e8-11e19ed0d5aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOND Arm Blood Pressure Monitor
Version Model NumberAES-U361
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
GS106953775650120 [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 Date2019-04-20

On-Brand Devices [FOND Arm Blood Pressure Monitor]

06953775650205AES-U612
06953775650199AES-U611
06953775650182AES-U631
06953775650175AES-U632
06953775650168AES-U512
06953775650151AES-U321
06953775650144AES-U311
06953775650137AES-U522
06953775650120AES-U361
06953775650113AES-U351
06953775650106AES-U151
06953775650090AES-U141
06953775650083AES-U131
06953775650069AES-U181
06953775650052AES-U171
06953775620147AES-U341
06953775620130AES-U331
06953775620123AES-U121
06953775620116AES-U161

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