Samsung ECG Monitor Application

GUDID 08806090792021

Samsung Electronics Co., Ltd.

Electrocardiographic monitor
Primary Device ID08806090792021
NIH Device Record Key6b684bc7-f193-4557-9514-664cdfba8c53
Commercial Distribution Discontinuation2020-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSamsung ECG Monitor Application
Version Model Number1.1
Company DUNS687967554
Company NameSamsung Electronics 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 Datefalse
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
GS108806090792021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDAElectrocardiograph Software For Over-The-Counter Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

On-Brand Devices [Samsung ECG Monitor Application ]

088060907920451.1
088060907920211.1

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