GUDIDData
gudid Primary ID: 362-021-010U

HME-Booster T-piece WFL Comfort + Hygrovent S HMEF (UDI 362-021-010U)

Manufactured by FLEXICARE MEDICAL LIMITED

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HME-Booster T-piece WFL Comfort + Hygrovent S HMEF - Primary ID 362-021-010U

Device Regulatory Overview

The HME-Booster T-piece WFL Comfort + Hygrovent S HMEF (Model/Catalog Number: 362-021-010U) is a medical device manufactured by FLEXICARE MEDICAL LIMITED. This product is indexed under FDA Product Code / Category Classification BTT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
362-021-010U
Product Code / EMDN
BTT
Device Name
Database Sync Date
2026-08-09 09:08:16

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 HME-Booster T-piece WFL Comfort + Hygrovent S HMEF?

The registered manufacturer of record for HME-Booster T-piece WFL Comfort + Hygrovent S HMEF is FLEXICARE MEDICAL LIMITED.

What is the Primary UDI-DI identifier for HME-Booster T-piece WFL Comfort + Hygrovent S HMEF?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 362-021-010U.

What classification code is assigned to this device?

This device is registered under product classification code BTT.

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