Kardia 12L

GUDID B210AC0270

Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders.

Alivecor, Inc.

Electrocardiograph, professional, multichannel

• Primary Device ID: B210AC0270
• NIH Device Record Key: 9b26556b-fd39-4fef-9f2f-66dd2a9160eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kardia 12L
• Version Model Number: AC-027
• Company DUNS: 078523613
• Company Name: Alivecor, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com
• Phone: (855) 338 8800
• Email: clinicalsupport@alivecor.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B210AC0270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232035

FDA Product Code

• DPS: 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: 2024-08-21
• Device Publish Date: 2024-08-13

Devices Manufactured by Alivecor, Inc.

• B210AC0270 - Kardia 12L: 2024-08-21Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders.
• B210AC0270 - Kardia 12L: 2024-08-21 Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using softwar
• B210AC0110 - KardiaBand System: 2024-04-01 The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, st
• B210AC0210 - KardiaMobile Card: 2022-07-21 The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, tran
• B210AC0190 - KardiaMobile 6L: 2020-05-11
• B210AC0090 - Kardia Mobile: 2018-07-06