Identity
- Trade Name
- Dutch, Hyperthermia Pump, 230V FDA UDI
- Generic Name
- Extravascular-circulation hyperthermia system FDA UDI
- Model / Reference
- 902-00001A-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20896128002132 FDA UDI
- 510(k) Number
- K152208 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Extravascular-circulation hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Dutch, Hyperthermia Pump, 230V by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K152208 also covers:
- 4.4 Liter Reservoir — Belmont Instrument Corp.
- HEAT EXCHANGER SET (1 Piece) — Belmont Instrument Corp.
- HP Procedure Kit — Belmont Instrument Corp.
- Hyperthermia Pump Accessory Kit — Belmont Instrument Corp.
- Hyperthermia Pump Cannula Connector — Belmont Instrument Corp.
- Hyperthermia Pump Procedure Kit — Belmont Instrument Corp.
- Hyperthermia Pump, 120V — Belmont Instrument Corp.
- Procedure Pack x1 — Belmont Instrument Corp.
- Straight In/Bifurcated Out Pt Line (1 Piece) — Belmont Instrument Corp.
- Straight In/Out Pt Line Kit — Belmont Instrument Corp.
- Straight Inflow/Bifurcated Outflow Pt Line Kit — Belmont Instrument Corp.
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
- Belmont Instrument Corp.
Sources (1)
- FDA UDI 9fe89dde-e7f1-4117-b899-1227038e533d 34 fields · synced May 31, 2026