ePatch Electrode-patch

GUDID B146EPE1

BRAEMAR MANUFACTURING, LLC

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