GUDIDData
gudid Primary ID: BC-300

MedicaLyte (UDI BC-300)

Manufactured by DIMESOL USA, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MedicaLyte - Primary ID BC-300

Device Regulatory Overview

The MedicaLyte (Model/Catalog Number: BC-300) is a medical device manufactured by DIMESOL USA, LLC. This product is indexed under FDA Product Code / Category Classification KPO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
BC-300
Product Code / EMDN
KPO
Device Name
Liquid Bicarbonate Concentrate
Database Sync Date
2026-08-09 09:31:19

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 MedicaLyte?

The registered manufacturer of record for MedicaLyte is DIMESOL USA, LLC.

What is the Primary UDI-DI identifier for MedicaLyte?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BC-300.

What classification code is assigned to this device?

This device is registered under product classification code KPO.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint