gudid
Primary ID: FL-10000U
FL-10000U (UDI FL-10000U)
Manufactured by FLEXICARE MEDICAL LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FL-10000U - Primary ID FL-10000U
Device Regulatory Overview
The FL-10000U (Model/Catalog Number: FL-10000U) 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
- FL-10000U
- Product Code / EMDN
- BTT
- Device Name
- Respiratory Humidifier Heater - 100 - 120V With Nema 5 - 15P 3 Pin Plug
- 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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of FL-10000U?
The registered manufacturer of record for FL-10000U is FLEXICARE MEDICAL LIMITED.
What is the Primary UDI-DI identifier for FL-10000U?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FL-10000U.
What classification code is assigned to this device?
This device is registered under product classification code BTT.
Similar Classification Devices (BTT)
Other Devices by FLEXICARE MEDICAL LIMITED
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