Midmark Digital ECG 4-000-0080

GUDID 00841709121319

Midmark Digital ECG from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient test results you need to make informed cardiac assessments and provide more efficient patient care. Kit includes Midmark Digital ECG device - USB version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable ECG Electrodes, Device silicon cover.

MIDMARK CORPORATION

Electrocardiographic ambulatory recorder
Primary Device ID00841709121319
NIH Device Record Keyb58f330f-c308-496f-a8e3-3a83b07b644f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMidmark Digital ECG
Version Model Number4-000-0080
Catalog Number4-000-0080
Company DUNS005036025
Company NameMIDMARK CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com
Phone+1(800)643-6275
Emailsupport@midmark.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841709121319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

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