Identity
- Trade Name
- EKG Patch Solution FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- Portable, 12-lead ECG testing kit. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Portable, 12-lead ECG testing kit. FDA UDI
Identifiers
- Catalog Number
- EPSK001CLPA020MG FDA UDI
- Primary DI / UDI-DI
- 00198715993158 FDA UDI
- FDA Product Code
- OEZ FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EKG Patch Solution by Mg Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Mg Medical Products Llc
Sources (1)
- FDA UDI 354aecc1-9354-4675-9f80-4fb9fa0ef3ec 36 fields · synced May 30, 2026