Embrace2 EM2-SB-S

GUDID 08538580061408

EMPATICA SRL

Home seizure monitoring system
Primary Device ID08538580061408
NIH Device Record Keyda1587c0-66cd-4e8d-ae86-e25fd9e95165
Commercial Distribution Discontinuation2020-02-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEmbrace2
Version Model NumberEmbrace
Catalog NumberEM2-SB-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
GS108538580061408 [Primary]

FDA Product Code

POSPhysiological Signal Based Seizure Monitoring System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-12
Device Publish Date2018-11-09

On-Brand Devices [Embrace2]

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

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