FDA UDI
In Commercial Distribution
🇺🇸 United States
MoMe® Kardia
DI: B690MK10
·
Model: 01854
·
Infobionic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MoMe® Kardia
- Primary DI
- B690MK10
- Version / Model
- 01854
- Company Name
- Infobionic, Inc.
- Labeler DUNS
- 078650138
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-23
- Public Version
- 3
- Public Version Date
- 2023-11-16
- Public Version Status
- Update
- Public Device Record Key
- eddf3e53-8cc4-4f53-96f7-f21aa96a65b4
Device Description
MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician 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
- No
- 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 |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36367 | Electrocardiography telemetric monitoring system transmitter | A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B690MK10 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160064 | 000 |