GUDIDData
gudid Primary ID: 8819

PremierPro (UDI 8819)

Manufactured by PRESTIGE AMERITECH, LTD.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PremierPro - Primary ID 8819

Device Regulatory Overview

The PremierPro (Model/Catalog Number: 8819) is a medical device manufactured by PRESTIGE AMERITECH, LTD.. This product is indexed under FDA Product Code / Category Classification KZD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
8819
Product Code / EMDN
KZD
Device Name
Pressure Infusion Bag, Reusable, 3000mL, Clear Back
Database Sync Date
2026-08-09 09:22:16

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 PremierPro?

The registered manufacturer of record for PremierPro is PRESTIGE AMERITECH, LTD..

What is the Primary UDI-DI identifier for PremierPro?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8819.

What classification code is assigned to this device?

This device is registered under product classification code KZD.

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