MobileECG System

GUDID 00860002827315

PC Based Wireless 12 Lead EKG Device

MEMTEC CORPORATION

Electrocardiograph, professional, single-channel
Primary Device ID00860002827315
NIH Device Record Key5fc353ee-9202-4626-b1ec-b6b5844402af
Commercial Distribution Discontinuation2029-11-15
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobileECG System
Version Model NumberMobileECG System
Company DUNS001048925
Company NameMEMTEC CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100860002827315 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

Devices Manufactured by MEMTEC CORPORATION

00860002827308 - Holter Monitor2019-11-25 Holter Monitor
00860002827315 - MobileECG System2019-11-25PC Based Wireless 12 Lead EKG Device
00860002827315 - MobileECG System2019-11-25 PC Based Wireless 12 Lead EKG Device

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