0.5L Hyperinflation System with Pressure Manometer (UDI 04710810100260)
Manufactured by GaleMed Corporation
Device Regulatory Overview
The 0.5L Hyperinflation System with Pressure Manometer (Model/Catalog Number: XTF0012) is a medical device manufactured by GaleMed Corporation. This product is indexed under FDA Product Code / Category Classification R02010101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- XTF0012
- Product Code / EMDN
- R02010101
- Device Name
- Hyperinflation Kit
- Database Sync Date
- 2026-08-09 16:28:57
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 0.5L Hyperinflation System with Pressure Manometer?
The registered manufacturer of record for 0.5L Hyperinflation System with Pressure Manometer is GaleMed Corporation.
What is the Primary UDI-DI identifier for 0.5L Hyperinflation System with Pressure Manometer?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04710810100260.
What classification code is assigned to this device?
This device is registered under product classification code R02010101.
Similar Classification Devices (R02010101)
- → BREATHING CIRCUITS, W/O WATER TRAP
- → Vital Signs™ Breathing Circuit, Pediatric, Disposable, 1.8 m/72 in
- → Vital Signsâ„¢ Breathing Circuit, Pediatric, Corrugated, Disposable, 2.4m / 96in, With Gas Sampling Straight Connector, HMEF Mini, Manual Bag 1L, Manual Ventilation Tube, Corrugated, 1.5 M, Gas Sampling Line, 3 mÂ
- → ALTECH
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