FDA UDI
In Commercial Distribution
🇺🇸 United States
Kardia 12L
DI: B210AC0270
·
Model: AC-027
·
Alivecor, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kardia 12L
- Primary DI
- B210AC0270
- Version / Model
- AC-027
- Company Name
- Alivecor, Inc.
- Labeler DUNS
- 078523613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-13
- Public Version
- 1
- Public Version Date
- 2024-08-21
- Public Version Status
- New
- Public Device Record Key
- 9b26556b-fd39-4fef-9f2f-66dd2a9160eb
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16231 | Electrocardiograph, professional, multichannel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B210AC0270 | HIBCC |
Customer Contacts
- Phone
- (855) 338 8800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232035 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 54 – 101 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity