Identity
- Trade Name
- Matrix Wearable FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter FDA UDI
- Model / Reference
- 009-400-0195 FDA UDI
- Description
- M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter FDA UDI
Identifiers
- Catalog Number
- 009-400-0195 FDA UDI
- Primary DI / UDI-DI
- 00815187020600 FDA UDI
- 510(k) Number
- K202456 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
FDA UDI
Combination Product
No
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 ambulatory recorder
Matrix Wearable by Global Instrumentation, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202456 also covers:
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
- Matrix Wearable — GLOBAL INSTRUMENTATION, LLC
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 d0d05e8a-6cb6-4ca3-ba0d-5aa185b5e061 35 fields · synced May 31, 2026