Identity
- Trade Name
- JAPANESE, RAPID INFUSER, 100 V, 750 ML/MIN FDA UDI
- Generic Name
- Warming/high-flow infusion pump FDA UDI
- Device Name
- FLUID WARMER, 100 V SYSTEM BOXED FDA UDI
- Model / Reference
- 903-00001-J FDA UDI
- Description
- FLUID WARMER, 100 V SYSTEM BOXED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20896128002019 FDA UDI
- 510(k) Number
- K032674 FDA UDI
- FDA Product Code
- LGZ FDA UDIFRN FDA UDI
- GMDN Term
- Warming/high-flow infusion pump 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
Japanese, Rapid Infuser, 100 V, 750 Ml/Min by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8c5ca705-b8f5-4922-b649-12ba9b27892e 35 fields · synced May 30, 2026