FDA UDI
In Commercial Distribution
🇺🇸 United States
Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG
DI: 05903021560001
·
Model: Type: PC Client
·
MEDICALGORITHMICS S A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG
- Primary DI
- 05903021560001
- Version / Model
- Type: PC Client
- Company Name
- MEDICALGORITHMICS S A
- Labeler DUNS
- 522657576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-18
- Public Version
- 7
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- db7b7412-7397-4ce0-b3a3-2283e3ad4982
Device Description
The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 41651 | Electrocardiographic long-term ambulatory recording analyser application software | A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903021560001 | GS1 |