GUDIDData
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enforcement Primary ID: Z-0970-2025

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; (UDI Z-0970-2025)

Manufactured by Adept Medical Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; - Primary ID Z-0970-2025

Device Regulatory Overview

The Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; (Model/Catalog Number: Unspecified) is a medical device manufactured by Adept Medical Ltd. This product is indexed under FDA Product Code / Category Classification Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068. within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

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Technical Specifications

Model Number
N/A
Device Name
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Database Sync Date
2026-08-09 10:06:54

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 Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;?

The registered manufacturer of record for Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; is Adept Medical Ltd.

What is the Primary UDI-DI identifier for Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0970-2025.

What classification code is assigned to this device?

This device is registered under product classification code Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068..

Other Devices by Adept Medical Ltd

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