Spectrum Wireless Battery (UDI 36010)
Manufactured by BAXTER HEALTHCARE CORPORATION
Device Regulatory Overview
The Spectrum Wireless Battery (Model/Catalog Number: 36010) is a medical device manufactured by BAXTER HEALTHCARE CORPORATION. This product is indexed under FDA Product Code / Category Classification MRZ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Kaguya Automated Peritoneal Dialysis System...
Sharesource Connectivity Platform for Use with the Amia Automated PD System...
Technical Specifications
- Model Number
- 36010
- Product Code / EMDN
- MRZ
- Device Name
- The wireless battery module provides power to the pump while disconnected from AC power, whether the pump is ON or OFF, and provides wireless connectivity. The wireless battery module runs independently of the pump and has its own operating software. The wireless battery module independently handles wireless network communication, file transfers, and auto-programming.
- Database Sync Date
- 2026-08-09 09:08:43
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Spectrum Wireless Battery?
The registered manufacturer of record for Spectrum Wireless Battery is BAXTER HEALTHCARE CORPORATION.
What is the Primary UDI-DI identifier for Spectrum Wireless Battery?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 36010.
What classification code is assigned to this device?
This device is registered under product classification code MRZ.
Similar Classification Devices (MRZ)
Other Devices by BAXTER HEALTHCARE CORPORATION
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint