gudid Primary ID: GoodKnight H2O

GoodKnight (UDI GoodKnight H2O)

Manufactured by SEFAM

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The GoodKnight (Model/Catalog Number: GoodKnight H2O) is a medical device manufactured by SEFAM. This product is indexed under FDA Product Code / Category Classification BTT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: GoodKnight H2O
Product Code / EMDN: BTT
Device Name: GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series.
Database Sync Date: 2026-08-09 09:52:14

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 GoodKnight?

The registered manufacturer of record for GoodKnight is SEFAM.

What is the Primary UDI-DI identifier for GoodKnight?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GoodKnight H2O.

What classification code is assigned to this device?

This device is registered under product classification code BTT.

Similar Classification Devices (BTT)

Other Devices by SEFAM

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