AcQMap® 800365-003

GUDID 00857042007210

Patient Electrode Kit 900100

ACUTUS MEDICAL, INC.

Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch Cardiac mapping system reference patch

• Primary Device ID: 00857042007210
• NIH Device Record Key: 52504b59-0c69-4f9c-b7b8-bc2a04622426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQMap®
• Version Model Number: 800365-003
• Catalog Number: 800365-003
• Company DUNS: 844418199
• Company Name: ACUTUS MEDICAL, INC.
• 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: true
• 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: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com
• Phone: (442) 232-6100
• Email: product.complaints@acutus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857042007210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190131

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2019-07-23
• Device Publish Date: 2019-07-15

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