Epatch Sensor

GUDID B146EP04

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: B146EP04
• NIH Device Record Key: 4d5b8e0a-4e35-43de-bd4a-2beecd3d1a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epatch Sensor
• Version Model Number: 900-0632-02
• Company DUNS: 049529118
• Company Name: BRAEMAR MANUFACTURING, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	B146EP04 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171410

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-09

On-Brand Devices [Epatch Sensor]

• B146EP080: 900-0632-05
• B146EP070: 900-0632-04
• B146EP060: 900-0632-03
• B146EP04: 900-0632-02
• B146EP030: 900-0632-01