FDA.reportPublic FDA data

Midmark Digital ECG

Primary DI
00841709121319
Brand
Midmark Digital ECG
Company
MIDMARK CORPORATION
Model
4-000-0080
Catalog number
4-000-0080
Device description
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.
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220526000HD+12, HD+15Cardioline S.P.A2023-05-15DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709121319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709121319008417091213198417091213190841709121319

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709110337Midmark153603LR-E153603LR-E2020-05-22
00841709110344Midmark153604CE153604CE2020-05-22
00841709110375Midmark153604LRCA-E153604LRCA-E2020-05-22
00841709110382Midmark153604LR-E153604LR-E2020-05-22
00841709111839Midmark153603C153603C2020-05-22
00841709108907Midmark153592-002153592-0022020-10-30
00841709108969Midmark153758-002153758-0022020-10-30
00841709107320Midmark153901-001153901-0012018-05-31
00841709107344Midmark153901-003153901-0032018-05-31
00841709107351Midmark153901-004153901-0042018-05-31
00841709107368Midmark153901-005153901-0052018-05-31
00841709107375Midmark153901-006153901-0062018-05-31
00841709109393Midmark153901-007153901-0072018-05-31
00841709109409Midmark153901-008153901-0082018-05-31
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709125638MidmarkLT-1100-002LT-1100-0022026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22