Identity
- Trade Name
- Controller FDA UDI
- Generic Name
- External electric-heating core temperature regulation system control unit FDA UDI
- Device Name
- The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Controller monitors current, zone power, the temperature sensors, and detects faults in the mattress or system. FDA UDI
- Model / Reference
- 2002 FDA UDI
- Description
- The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Controller monitors current, zone power, the temperature sensors, and detects faults in the mattress or system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851446007012 FDA UDI
- 510(k) Number
- K132454 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External electric-heating core temperature regulation system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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: External electric-heating core temperature regulation system control unit
Controller by Vitaheat Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External electric-heating core temperature regulation system control unit.
- Pintler Patient Warming System — Pintler Medical · Class II
Cleared under the same submission
K132454 also covers:
- AC Power Adapter — Vitaheat Medical, LLC
- AC Power Adapter Subassembly Kit — Vitaheat Medical, LLC
- Battery — Vitaheat Medical, LLC
- Battery Charger — Vitaheat Medical, LLC
- Battery Power Subassembly — Vitaheat Medical, LLC
- Patient Warming Mattress — Vitaheat Medical, LLC
- VitaHEAT UB3 Patient Warming System - AC Power — Vitaheat Medical, LLC
- VitaHEAT UB3 Patient Warming System - Battery Power — Vitaheat Medical, LLC
- VitaHEAT UB3 Patient Warming System- Battery and AC Power — Vitaheat Medical, LLC
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
- Vitaheat Medical, LLC
Sources (1)
- FDA UDI 28b0f308-e42c-4705-b536-022463d94f00 35 fields · synced May 30, 2026