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physIQ Heart Rhythm and Respiration Module
FDA UDIClass II (US FDA UDI)
by Physiq, Inc
Identity
- Trade Name
- physIQ Heart Rhythm and Respiration Module FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- physIQ Heart Rhythm and Respiratory Module FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- physIQ Heart Rhythm and Respiratory Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860004366256 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiography telemetric monitoring system
physIQ Heart Rhythm and Respiration Module by Physiq, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Heartrak Smart Rev 5 — UNIVERSAL MEDICAL, INC. · Class II
- ER9W CDMA First Call Med — Braemar Manufacturing, LLC · Class II
- Heartrak Smart Wireless Rev 1 — UNIVERSAL MEDICAL, INC. · Class II
- RhythmStar — RhythMedix, LLC · Class II
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
- Physiq, Inc
Sources (1)
- FDA UDI 0e469dd8-8c8d-4942-988c-bc546f562265 34 fields · synced May 30, 2026