Identity
- Trade Name
- CPR3H FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- MicroPort CRM CPR3H telemetry head for SmartTouch FDA UDI
- Model / Reference
- GB78 FDA UDI
- Description
- MicroPort CRM CPR3H telemetry head for SmartTouch FDA UDI
Identifiers
- Catalog Number
- GB78 FDA UDI
- Primary DI / UDI-DI
- 08031527017013 FDA UDI
- PMA Number
- P980049 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Medical networking interface unit 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
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
No
FDA UDI
Category: Medical networking interface unit
Cpr3h by Microport Crm Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical networking interface unit.
- Polytel — Polymap Wireless, LLC · Class I
- Compumedics Grael — COMPUMEDICS LIMITED · Class II
- BodyGuardian — PREVENTICE TECHNOLOGIES, INC. · Class II
- LATITUDE® Communicator — Boston Scientific · Class III
- DreamStation — Respironics, Inc. · Class I
- ZeroWire G2 — NDS SURGICAL IMAGING, LLC. · Class II
- ZeroWire — NDS SURGICAL IMAGING, LLC. · Class II
- DreamStation — Respironics, Inc. · Class I
Cleared under the same submission
P980049 also covers:
- 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
- RMS — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microport Crm Srl
Sources (1)
- FDA UDI 181a1a8b-38a5-4943-85e1-54aa20d61953 35 fields · synced Jun 1, 2026