Epatch Electrode-patch

GUDID B146EPE20

BRAEMAR MANUFACTURING, LLC

Electrocardiographic lead set, reusable

• Primary Device ID: B146EPE20
• NIH Device Record Key: 09cb1d6a-e06d-462a-b110-919f37ac2f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epatch Electrode-patch
• Version Model Number: 390-0230-02
• Company DUNS: 049529118
• Company Name: BRAEMAR MANUFACTURING, LLC
• Device Count: 2
• 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	B146EPE20 [Primary]
HIBCC	B146EPE21 [Unit of Use]

FDA Product Code

• IKD: Cable, Electrode

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-04

On-Brand Devices [Epatch Electrode-patch]

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