Identity
- Trade Name
- 18-B REFURB. IR REMOTE REC. FDA UDI
- Generic Name
- Cardiac arrhythmia monitoring system FDA UDI
- Model / Reference
- 300-0277-25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816787020113 FDA UDI
- 510(k) Number
- K944495 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Cardiac arrhythmia monitoring system 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
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
Yes
FDA UDI
Category: Cardiac arrhythmia monitoring system
18-B Refurb. Ir Remote Rec. by Parks Medical Electronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac arrhythmia monitoring system.
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- Patient Monitor — General Meditech. Inc. · Class II
- Holter Analysis Software — North East Monitoring, Inc. · Class II
- Vios Monitoring System Central Station Monitor — Murata Vios, Inc. · Class I
- Vios Monitoring System Mobile Application — Murata Vios, Inc. · Class II
- Patient Monitor — General Meditech. Inc. · Class II
- Patient Monitor — General Meditech. Inc. · Class II
Cleared under the same submission
K944495 also covers:
- 18-B IR REMOTE RECEIVER — PARKS MEDICAL ELECTRONICS, INC.
- 19-B IR REMOTE RECEIVER — PARKS MEDICAL ELECTRONICS, INC.
- 2100-SX & 3100-B REMOTE CHARG- — PARKS MEDICAL ELECTRONICS, INC.
- 2100-SX2 FINAL FEATURE ITEM — PARKS MEDICAL ELECTRONICS, INC.
- FINAL ASSY 2100-REMOTE 18-BR — PARKS MEDICAL ELECTRONICS, INC.
- REFURBISHED 18-BR REMOTE — PARKS MEDICAL ELECTRONICS, INC.
- REFURBISHED 19-B IR REMOTE RECEIVER — PARKS MEDICAL ELECTRONICS, INC.
- REFURBISHED 2100-SX/3100-B IR — PARKS MEDICAL ELECTRONICS, INC.
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
- Parks Medical Electronics, Inc.
Sources (1)
- FDA UDI 0e354515-7f21-4c29-911b-a7a74b010323 34 fields · synced Jun 1, 2026