Identity
- Trade Name
- Rhythmia™ Mapping System FDA UDI
- Generic Name
- Basic power supply, reusable FDA UDI
- Device Name
- Rhythmia Power Supply FDA UDI
- Model / Reference
- M004RAPWR0 FDA UDI
- Description
- Rhythmia Power Supply FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729841906 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Basic power supply, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic power supply, reusable
Rhythmia™ Mapping System by Boston Scientific — 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
- Boston Scientific
Sources (1)
- FDA UDI e037b79d-151c-4af4-b3e0-20cce4c49c80 33 fields · synced Jun 1, 2026