ePatch Electrode-patch

GUDID B146EPE1

BRAEMAR MANUFACTURING, LLC

Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch Ambulatory recorder conductive patch

Primary Device ID	B146EPE1
NIH Device Record Key	6d856fd7-5184-4b4a-8666-e257fc0fab45
Commercial Distribution Status	In Commercial Distribution
Brand Name	ePatch Electrode-patch
Version Model Number	02-00168
Company DUNS	049529118
Company Name	BRAEMAR MANUFACTURING, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B146EPE0 [Primary]
HIBCC	B146EPE1 [Package] Contains: B146EPE0 Package: Box [40 Units] In Commercial Distribution

FDA Product Code

DRX	Electrode, Electrocardiograph

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-08
Device Publish Date	2022-03-31

On-Brand Devices [ePatch Electrode-patch]

B146EPE30	390-0240-02
B146EPE20	390-0230-02
B146EPE1	02-00168