N/A yes

GUDID 16953825908468

N/A

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID16953825908468
NIH Device Record Keydb530bd1-23a9-4b2a-886c-7ce186cb2c71
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberU80AH
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 Datefalse
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
GS106953825908461 [Primary]
GS116953825908468 [Package]
Contains: 06953825908461
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 Date2024-08-01
Device Publish Date2024-07-24

On-Brand Devices [N/A]

06953825905729U81V
06953825905958U82E
06953825905941U81E
16953825906341U82NH
16953825906402U82V
16953825906525U85W
16953825906594U80W
16953825906617U80EH
16953825906945N/A
16953825906921N/A
16953825907096U81CH
16953825907089U82V
16953825907195U81U
1695382590720181V
16953825907423U80N
16953825907553U80A
16953825907706U82V
16953825908116N/A
16953825908413U80Y
16953825908468N/A
16953825908697N/A
16953825908659N/A
16953825908734n/A
16953825908772U87E
16953825908833U80B

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