ePatch electrode-patch

GUDID B146EPE30

BRAEMAR MANUFACTURING, LLC

Ambulatory recorder conductive patch

• Primary Device ID: B146EPE30
• NIH Device Record Key: a56ace27-29fc-491a-ba70-b844e93e5989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ePatch electrode-patch
• Version Model Number: 390-0240-02
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B146EPE30 [Primary]
HIBCC	B146EPE31 [Unit of Use]

FDA Product Code

• DRX: Electrode, Electrocardiograph
• 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: 2019-10-08

On-Brand Devices [ePatch electrode-patch]

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