Embrace2 EM2-BB-S

GUDID 00853858006119

EMPATICA SRL

Home seizure monitoring system
Primary Device ID00853858006119
NIH Device Record Keyc297cb00-c90a-4578-8b70-f471462899a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace2
Version Model NumberEmbrace
Catalog NumberEM2-BB-S
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 Numbertrue
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
GS100853858006119 [Primary]

FDA Product Code

POSPhysiological Signal Based Seizure Monitoring System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-19
Device Publish Date2020-02-11

On-Brand Devices [Embrace2]

08538580061408Embrace
08538580061330Embrace
08538580061262Embrace
08538580061194Embrace
08538580061026Embrace
00853858006140Embrace
00853858006133Embrace
00853858006126Embrace
00853858006119Embrace
00853858006102Embrace

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