Cardea SOLO M300-5

GUDID 10857553006112

Cardea SOLO Wearable Sensor (M300)

CARDIAC INSIGHT, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 10857553006112
• NIH Device Record Key: e9743a53-be40-4cc1-a912-9a5c2f05afd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardea SOLO
• Version Model Number: M300-5
• Catalog Number: M300-5
• Company DUNS: 827419834
• Company Name: CARDIAC INSIGHT, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 2065962060
• Email: support@cardiacinsightinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857553006115 [Unit of Use]
GS1	10857553006112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162503

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-07-31

On-Brand Devices [Cardea SOLO]

• 00857553006139: Cardea SOLO PC Software - ECG analysis software (D300)
• 00857553006122: Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
• 10857553006112: Cardea SOLO Wearable Sensor (M300)