Identity
- Trade Name
- Midmark Digital ECG FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 4-000-0080 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 4-000-0080 FDA UDI
- Primary DI / UDI-DI
- 00841709121319 FDA UDI
- 510(k) Number
- K220526 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic ambulatory recorder
Midmark Digital ECG by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA UDI b58f330f-c308-496f-a8e3-3a83b07b644f 36 fields · synced Jun 8, 2026