Identity
- Trade Name
- Matrix Mini ECG Module Kit FDA UDI
- Generic Name
- Electrocardiographic monitor FDA UDI
- Device Name
- Module + USB + Patient Cable 3L AHA 90815187020016; ECG Module 90815187020054; Patient Cable 3L AHA 90815187020023; ECG Module USB Cable (18") 90815187020030; ECG Mounting Accessory, ACM, WALL FDA UDI
- Model / Reference
- 6000-ECG3A FDA UDI
- Description
- Module + USB + Patient Cable 3L AHA 90815187020016; ECG Module 90815187020054; Patient Cable 3L AHA 90815187020023; ECG Module USB Cable (18") 90815187020030; ECG Mounting Accessory, ACM, WALL FDA UDI
Identifiers
- Catalog Number
- 6000-ECG3A FDA UDI
- Primary DI / UDI-DI
- 90815187020085 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiographic monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic monitor
Matrix Mini ECG Module Kit by Global Instrumentation, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Global Instrumentation, Llc
Sources (1)
- FDA UDI eeb39ed7-4ce4-4590-9dc1-8f805415317b 34 fields · synced Jun 6, 2026