Identity
- Trade Name
- RMS FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- Remote Monitoring Software FDA UDI
- Model / Reference
- RMS FDA UDI
- Description
- Remote Monitoring Software FDA UDI
Identifiers
- Catalog Number
- RMS FDA UDI
- Primary DI / UDI-DI
- 08031527021188 FDA UDI
- PMA Number
- P980049 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class III 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiology information system application software
Rms by Microport Crm Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiology information system application software.
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- EZLink — SCOTTCARE CORPORATION, THE · Class II
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- Epicardia 5000 — MEDICOMP, INC. · Class II
Cleared under the same submission
P980049 also covers:
- CPR3H — MICROPORT CRM SRL
- CPR4 — MICROPORT CRM SRL
- Intensia — MICROPORT CRM SRL
- Intensia — MICROPORT CRM SRL
- PLATINIUM — MICROPORT CRM SRL
- PLATINIUM — MICROPORT CRM SRL
- PLATINIUM — MICROPORT CRM SRL
- PLATINIUM — MICROPORT CRM SRL
- Paradym RF — MICROPORT CRM SRL
- Paradym RF — MICROPORT CRM SRL
- SMARTVIEW — MICROPORT CRM SRL
- SMARTVIEW — MICROPORT CRM SRL
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 III | Pending data |
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Manufacturer
- Manufacturer
- Microport Crm Srl
Sources (1)
- FDA UDI 9b8c75db-eba7-4402-ab5b-63f30da55ff2 35 fields · synced May 30, 2026