GAM MED

GUDID 16953825908642

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID16953825908642
NIH Device Record Key6c234254-a368-491b-ac0b-4d9ed23504c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGAM MED
Version Model NumberU81D
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
GS106953825908645 [Primary]
GS116953825908642 [Package]
Contains: 06953825908645
Package: Carton [28 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 Date2024-09-03
Device Publish Date2024-08-26

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

16953825908864 - Premier HEALTH SOLUTONS2024-11-04
16953825908871 - Mitdir2024-11-04
16953825908888 - Zybs Medical2024-11-04
16953825908840 - AlphagoMed2024-11-01
16953825908857 - Andesfit Health2024-11-01
16953825908833 - N/A2024-10-31
16953825908796 - urion2024-10-22
16953825908802 - urion2024-10-22

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