GUDIDData
eudamed_udi Primary ID: 05420040802092

FB (UDI 05420040802092)

Manufactured by NIPRO CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FB - Primary ID 05420040802092

Device Regulatory Overview

The FB (Model/Catalog Number: FB 05U-GJ) is a medical device manufactured by NIPRO CORPORATION. This product is indexed under FDA Product Code / Category Classification F01060102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
FB 05U-GJ
Product Code / EMDN
F01060102
Device Name
HEMODIALYZER
Database Sync Date
2026-08-09 16:45:49

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 FB?

The registered manufacturer of record for FB is NIPRO CORPORATION.

What is the Primary UDI-DI identifier for FB?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05420040802092.

What classification code is assigned to this device?

This device is registered under product classification code F01060102.

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