FDA UDI
In Commercial Distribution
🇺🇸 United States
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System
DI: 05903021560025
·
Model: Type: PECGT-IIIV
·
MEDICALGORITHMICS S A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System
- Primary DI
- 05903021560025
- Version / Model
- Type: PECGT-IIIV
- Company Name
- MEDICALGORITHMICS S A
- Labeler DUNS
- 522657576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-09
- Public Version
- 3
- Public Version Date
- 2018-07-23
- Public Version Status
- Update
- Public Device Record Key
- a2034099-4c58-4ee3-8b8d-ded522f65958
Device Description
The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-IIIV is inteded for use in CDMA cellular networks.
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 |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31733 | Electrocardiography telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903021560025 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152550 | 000 |