GUDIDData
gudid Primary ID: 71040D

CO2MPACT (UDI 71040D)

Manufactured by US Endoscopy

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CO2MPACT - Primary ID 71040D

Device Regulatory Overview

The CO2MPACT (Model/Catalog Number: 71040D) is a medical device manufactured by US Endoscopy. This product is indexed under FDA Product Code / Category Classification FCX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
71040D
Product Code / EMDN
FCX
Device Name
CO2MPACT EVALUATION KIT. The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
Database Sync Date
2026-08-09 09:19:08

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 CO2MPACT?

The registered manufacturer of record for CO2MPACT is US Endoscopy.

What is the Primary UDI-DI identifier for CO2MPACT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 71040D.

What classification code is assigned to this device?

This device is registered under product classification code FCX.

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