Identity
- Trade Name
- EXPRESS FLUID WARMER FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Model / Reference
- FW-300-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- M535FW300D0 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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
Yes
FDA UDI
Category: Conduction blood/fluid warmer
Express Fluid Warmer by NxStage Medical, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NxStage Medical, Inc.
Sources (2)
- FDA UDI 2929cce9-1b17-4c0f-a744-80681afb9d2b 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026