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Epatch Electrode-patch

FDA UDI

Class II (US FDA UDI)

by Braemar Manufacturing, LLC

Identity

Trade Name
Epatch Electrode-patch FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Model / Reference
390-0230-02 FDA UDI

Identifiers

Primary DI / UDI-DI
B146EPE20 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1175 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: Electrocardiographic lead set, reusable

Epatch Electrode-patch by Braemar Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Braemar Manufacturing, LLC

Sources (1)

  • FDA UDI 09cb1d6a-e06d-462a-b110-919f37ac2f67 32 fields · synced Jun 9, 2026