AlphaMed

GUDID 06953825903787

Shenzhen Urion Technology Co., Ltd

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 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 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 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06953825903787
NIH Device Record Keyd2b4994f-a1b3-4f69-a5e3-f85d159076a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlphaMed
Version Model NumberU80X
Company DUNS421294358
Company NameShenzhen Urion Technology Co., Ltd
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 Datetrue
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
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [Primary]
GS106953825903787 [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
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
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 Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [AlphaMed]

06953825902766U60EH
06953825902759U60CH
06953825902742U80R
06953825902735U80B
06953825902728U80EH
06953825902179U80B
06953825901981U80BH
06953825901974U80B
06953825901967U80A
06953825901950U80AH
06953825901943U60AH
06953825901936U60A
06953825905019U81M
06953825909031HET-R171
06953825903787U80X

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