GUDIDData
gudid Primary ID: Fenom Pro Mouthpieces, Box of 50

CAIRE Diagnostics (UDI Fenom Pro Mouthpieces, Box of 50)

Manufactured by Caire Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CAIRE Diagnostics - Primary ID Fenom Pro Mouthpieces, Box of 50

Device Regulatory Overview

The CAIRE Diagnostics (Model/Catalog Number: Fenom Pro Mouthpieces, Box of 50) is a medical device manufactured by Caire Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification MXA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Fenom Pro Mouthpieces, Box of 50
Product Code / EMDN
MXA
Device Name
Box of 50 Fenom Pro Mouthpieces, PN 810-0006Sold in box of 50 only, individual mouthpieces are not for retail or commercial saleEach mouthpiece is individually packaged
Database Sync Date
2026-08-09 09:49:17

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 CAIRE Diagnostics?

The registered manufacturer of record for CAIRE Diagnostics is Caire Diagnostics Inc..

What is the Primary UDI-DI identifier for CAIRE Diagnostics?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Fenom Pro Mouthpieces, Box of 50.

What classification code is assigned to this device?

This device is registered under product classification code MXA.

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