GUDIDData
eudamed_udi Primary ID: 06945429023800

High Frequency Chest Wall Oscillator (UDI 06945429023800)

Manufactured by Shenzhen Comen Medical Instruments Co.,LTD.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for High Frequency Chest Wall Oscillator - Primary ID 06945429023800

Device Regulatory Overview

The High Frequency Chest Wall Oscillator (Model/Catalog Number: PK6) is a medical device manufactured by Shenzhen Comen Medical Instruments Co.,LTD.. This product is indexed under FDA Product Code / Category Classification Z12159009 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PK6
Product Code / EMDN
Z12159009
Device Name
High Frequency Chest Wall Oscillator
Database Sync Date
2026-08-09 16:46:36

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 High Frequency Chest Wall Oscillator?

The registered manufacturer of record for High Frequency Chest Wall Oscillator is Shenzhen Comen Medical Instruments Co.,LTD..

What is the Primary UDI-DI identifier for High Frequency Chest Wall Oscillator?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06945429023800.

What classification code is assigned to this device?

This device is registered under product classification code Z12159009.

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