Identity
- Trade Name
- nGEN Pump FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- Irrigation Pump FDA UDI
- Model / Reference
- D139702 FDA UDI
- Description
- Irrigation Pump FDA UDI
Identifiers
- Catalog Number
- D139702 FDA UDI
- Primary DI / UDI-DI
- 10846835017472 FDA UDI
- PMA Number
- P990071 FDA UDI
- FDA Product Code
- LBP FDA UDIOAD FDA UDIDRF FDA UDIOAE FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3450 FDA UDI870.1220 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: Cardiac radio-frequency ablation system generator
nGEN Pump by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P990071 also covers:
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
- Biosense Webster Inc
Sources (1)
- FDA UDI 04e2737b-8953-4ff4-b5d4-a023522af303 37 fields · synced May 30, 2026