gudid Primary ID: PCK2001

Infinity (UDI PCK2001)

Manufactured by ZEVEX INTERNATIONAL, INC.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Infinity (Model/Catalog Number: PCK2001) is a medical device manufactured by ZEVEX INTERNATIONAL, INC.. This product is indexed under FDA Product Code / Category Classification LZH within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: PCK2001
Product Code / EMDN: LZH
Device Name: Enteralite Infinity Super Mini Backpack, Black
Database Sync Date: 2026-08-09 09:46:39

Full Regulatory Attributes

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{
    "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 Infinity?

The registered manufacturer of record for Infinity is ZEVEX INTERNATIONAL, INC..

What is the Primary UDI-DI identifier for Infinity?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PCK2001.

What classification code is assigned to this device?

This device is registered under product classification code LZH.

Similar Classification Devices (LZH)

Other Devices by ZEVEX INTERNATIONAL, INC.

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