GUDIDData
gudid Primary ID: 490540

BD SurePath (UDI 490540)

Manufactured by TRIPATH IMAGING, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BD SurePath - Primary ID 490540

Device Regulatory Overview

The BD SurePath (Model/Catalog Number: 490540) is a medical device manufactured by TRIPATH IMAGING, INC.. This product is indexed under FDA Product Code / Category Classification MKQ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
490540
Product Code / EMDN
MKQ
Device Name
SurePath GYN Collection Kit contains 100 collection vials used to preserve, transport, and store cevical cytology samples.
Database Sync Date
2026-08-09 10:02:46

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 BD SurePath?

The registered manufacturer of record for BD SurePath is TRIPATH IMAGING, INC..

What is the Primary UDI-DI identifier for BD SurePath?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 490540.

What classification code is assigned to this device?

This device is registered under product classification code MKQ.

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