Identity
- Trade Name
- Rhythmia™ Mapping System FDA UDI
- Generic Name
- Cardiac mapping system FDA UDI
- Device Name
- Breakout Box A In FDA UDI
- Model / Reference
- M004RH11000 FDA UDI
- Description
- Breakout Box A In FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729841982 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac mapping system 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac mapping system
Rhythmia™ Mapping System by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping system.
- Affera™ Integrated Mapping System — MEDTRONIC, INC. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- OptiMap™ Workstation — Cortex, Inc. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 765dff6c-2775-4075-a0ac-15d048eb5082 33 fields · synced May 30, 2026