GUDIDData
gudid Primary ID: 36010

Spectrum Wireless Battery (UDI 36010)

Manufactured by BAXTER HEALTHCARE CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Spectrum Wireless Battery - Primary ID 36010

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.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2174-2021 View Full Alert →

Kaguya Automated Peritoneal Dialysis System...

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ID: Z-2173-2021 View Full Alert →

Sharesource Connectivity Platform for Use with the Amia Automated PD System...

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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
}
                            

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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.

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