C6 Monitor A13, Verizon

GUDID B146C6M90

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: B146C6M90
• NIH Device Record Key: 34b8605b-2a18-464f-b4f7-38af7ca4ba6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C6 Monitor A13, Verizon
• Version Model Number: 02-02118
• 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	B146C6M90 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153473

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by BRAEMAR MANUFACTURING, LLC

• B146C6M20 - C6 Monitor UGW: 2023-12-14
• B146EP2510 - ePatch 2.5, BTH: 2023-12-13
• B146EP2520 - ePatch 2.5, BTI: 2023-11-30
• B146C6M60 - C6 Monitor A10e, Sprint: 2023-06-23
• B146C6M80 - C6 Monitor A13, T Mobile: 2023-06-23
• B146C6M90 - C6 Monitor A13, Verizon: 2023-06-23
• B146C6M90 - C6 Monitor A13, Verizon: 2023-06-23
• B146EP2R10 - ePatch 2.0 rebuilt: 2022-07-21
• B146EPE1 - ePatch Electrode-patch: 2022-04-08