Telli Health LLC

GUDID 06953825905194

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor
Primary Device ID06953825905194
NIH Device Record Keyb0cd7489-c986-406a-a689-0ece06780056
Commercial Distribution StatusIn Commercial Distribution
Brand NameTelli Health LLC
Version Model NumberUFR101
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
GS106953825905194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-27
Device Publish Date2021-08-19

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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