Identity
- Trade Name
- EKG Patch (Medium) FDA UDI
- Generic Name
- Ambulatory recorder conductive patch FDA UDI
- Device Name
- Electrocardiograph Electrode Patch (Adult Medium) FDA UDI
- Model / Reference
- Adult 2.0 Medium FDA UDI
- Description
- Electrocardiograph Electrode Patch (Adult Medium) FDA UDI
Identifiers
- Catalog Number
- PA020AOM0213C FDA UDI
- Primary DI / UDI-DI
- 00860007764400 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Ambulatory recorder conductive patch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ambulatory recorder conductive patch
EKG Patch (Medium) by Mg Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory recorder conductive patch.
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- Universal electrode patch — Braemar Manufacturing, LLC · Class II
- Universal electrode-patch — Braemar Manufacturing, LLC · Class II
- EKG Patch (Pediatric 2) — MG MEDICAL PRODUCTS LLC · Class II
- EKG Patch (Pediatric 1) — MG MEDICAL PRODUCTS LLC · Class II
- EKG Patch (Pediatric 3) — MG MEDICAL PRODUCTS LLC · Class II
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 b187648c-7824-44c0-9c10-c8e06e7bb797 36 fields · synced May 30, 2026