Identity
- Trade Name
- WA Holter System FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- HR100 Holter Repair Exchange FDA UDI
- Model / Reference
- HR100 FDA UDI
- Description
- HR100 Holter Repair Exchange FDA UDI
Identifiers
- Catalog Number
- 402810 FDA UDI
- Primary DI / UDI-DI
- 90815187020276 FDA UDI
- 510(k) Number
- K051730 FDA UDI
- FDA Product Code
- MLO 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic ambulatory recorder
WA Holter System 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
K051730 also covers:
- Battery Cover — GLOBAL INSTRUMENTATION, LLC
- Battery Cover — GLOBAL INSTRUMENTATION, LLC
- GI Holter System — GLOBAL INSTRUMENTATION, LLC
- GI Holter System — GLOBAL INSTRUMENTATION, LLC
- GI Holter System — GLOBAL INSTRUMENTATION, LLC
- GI Holter System — GLOBAL INSTRUMENTATION, LLC
- GI Holter System — GLOBAL INSTRUMENTATION, LLC
- M12 System — GLOBAL INSTRUMENTATION, LLC
- Matrix Holter System — GLOBAL INSTRUMENTATION, LLC
- Matrix Holter System — GLOBAL INSTRUMENTATION, LLC
- Matrix Holter System — GLOBAL INSTRUMENTATION, LLC
- Matrix Holter System — 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 95fafc58-ab5c-4a7d-b1b6-1f46c239c678 35 fields · synced May 30, 2026