GUDIDData
gudid Primary ID: TUB-10

TUB10 (UDI TUB-10)

Manufactured by Inogen, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TUB10 - Primary ID TUB-10

Device Regulatory Overview

The TUB10 (Model/Catalog Number: TUB-10) is a medical device manufactured by Inogen, Inc.. This product is indexed under FDA Product Code / Category Classification SDT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
TUB-10
Product Code / EMDN
SDT
Device Name
1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 10 therapy sessions and 10 disposable mouthpieces
Database Sync Date
2026-08-09 09:52:17

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 TUB10?

The registered manufacturer of record for TUB10 is Inogen, Inc..

What is the Primary UDI-DI identifier for TUB10?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TUB-10.

What classification code is assigned to this device?

This device is registered under product classification code SDT.

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