Identity
- Trade Name
- Universal electrode patch FDA UDI
- Generic Name
- Ambulatory recorder conductive patch FDA UDI
- Model / Reference
- 02-01909 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B146PE30 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
Yes
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
Universal electrode patch by Braemar Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- EKG Patch (Large) — 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
- Braemar Manufacturing, LLC
Sources (1)
- FDA UDI bb20703d-e261-48a8-aa36-1b265746cbb2 32 fields · synced Jun 9, 2026