ORIGINMEDICAL Yes

GUDID 16953825907461

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
Primary Device ID16953825907461
NIH Device Record Key95c6aa39-87cf-41a9-9bdd-4ada14cfbd21
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIGINMEDICAL
Version Model NumberU82RH
Catalog NumberYes
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106953825907464 [Primary]
GS116953825907461 [Package]
Contains: 06953825907464
Package: Carton [20 Units]
In Commercial Distribution

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 Date2023-08-18
Device Publish Date2023-08-10

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

16953825903494 - ALPHAMED2024-04-23 N/A
16953825908116 - N/A2024-04-23 N/A
16953825908055 - Nature Therapy2024-04-11
16953825908062 - VERWINT2024-04-08
16953825908017 - ALPHAMED2024-04-01 N/A
16953825908048 - Glucoracy2024-04-01 N/A
16953825907706 - N/A2023-12-04
16953825907669 - WUJIE2023-11-22
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