gudid
Primary ID: FL9000-04STRU
FL9000 (UDI FL9000-04STRU)
Manufactured by FLEXICARE MEDICAL LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FL9000 - Primary ID FL9000-04STRU
Device Regulatory Overview
The FL9000 (Model/Catalog Number: FL9000-04STRU) 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
- FL9000-04STRU
- Product Code / EMDN
- BTT
- Device Name
- Respiratory Humidifier Single Use Temperature Probe (Sterile)
- 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 FL9000?
The registered manufacturer of record for FL9000 is FLEXICARE MEDICAL LIMITED.
What is the Primary UDI-DI identifier for FL9000?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FL9000-04STRU.
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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