Identity
- Trade Name
- Battery Power Subassembly FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration. FDA UDI
- Model / Reference
- 300126 FDA UDI
- Description
- The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851446007081 FDA UDI
- 510(k) Number
- K132454 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Primary battery 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: Noninvasive device battery chargerPrimary battery
Battery Power Subassembly by Vitaheat Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Primary battery.
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- LIFEPAK® 500 Li-SO2 Non-Rechargeable Battery — PHYSIO-CONTROL, Inc. · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- LIFEPAK® 500 Li-SO2 Non-Rechargeable Battery — PHYSIO-CONTROL, Inc. · Class III
- Intellisense® Battery Powerheart® G5 — Zoll Medical Corporation · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- R&D Batteries, Inc. — R & D BATTERIES, INC. · Class III
- Powerheart® G3 Battery — Zoll Medical Corporation · Class III
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
- Controller — 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 f037305b-0042-49e4-af4d-04317a08dc18 35 fields · synced May 29, 2026