Empatica Health Monitoring Platform

GUDID 00853858006249

EMPATICA SRL

Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use Multiple vital physiological parameter monitoring system, home-use
Primary Device ID00853858006249
NIH Device Record Key53f6d2e8-d8ef-4c0e-940a-929f54792f69
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpatica Health Monitoring Platform
Version Model NumberCare App iOS
Company DUNS430141750
Company NameEMPATICA SRL
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853858006249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-02
Device Publish Date2022-11-24

On-Brand Devices [Empatica Health Monitoring Platform]

00853858006263Care Portal
00853858006256Care App Android Version
00853858006249Care App iOS
00853858006232EmbracePlus

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