FDA UDI
In Commercial Distribution
🇺🇸 United States
Smartheart
DI: 07290008960380
·
Model: 3.3
·
SHL TELEMEDICINE INTERNATIONAL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Smartheart
- Primary DI
- 07290008960380
- Version / Model
- 3.3
- Catalog Number
- E-486-0
- Company Name
- SHL TELEMEDICINE INTERNATIONAL LTD.
- Labeler DUNS
- 531817906
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-09
- Public Version
- 1
- Public Version Date
- 2025-12-17
- Public Version Status
- New
- Public Device Record Key
- 17bd68dc-940a-449d-8565-10a5cce8eb71
Device Description
The SmartHeart is a portable battery powered, 12-lead ECG and rhythm strip device with Bluetooth connection. SmartHeart acquires ECG data via electrodes on the housing and the electrode belt placed on the chest and electrodes in the left and right armpits and the waist. SmartHeart transmits the data in real-time to a suitable Bluetooth communication device (smartphone or tablet) equipped with a Mobile Application so that it can be forwarded to the remote location equipped by Cardio Medical Center Vision (K003392) or equivalent software for a medical professional review.
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | Cardiovascular | 870.2920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62641 | Electrocardiograph, home-use | A device intended to be used by a layperson in the home 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 may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290008960380 | GS1 | ||||
| Previous | 07290008960359 | GS1 |
Customer Contacts
- Phone
- 1-866-745-8356
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113514 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Belt - 32cm | ||
| Height | 1.5 | Centimeter | |
| Width | 8.5 | Centimeter | |
| Length | 11 | Centimeter | |
| Weight | 240 | Gram |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius