nCPAP Prong, #5 w/ Pressure Port Elbow (UDI 06923980114311)
Manufactured by GaleMed (Xiamen) Co., Ltd.
Device Regulatory Overview
The nCPAP Prong, #5 w/ Pressure Port Elbow (Model/Catalog Number: AN0015) is a medical device manufactured by GaleMed (Xiamen) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification R02010401 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AN0015
- Product Code / EMDN
- R02010401
- Device Name
- Disposable Bubble CPAP system
- Database Sync Date
- 2026-08-09 17:43:46
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 nCPAP Prong, #5 w/ Pressure Port Elbow?
The registered manufacturer of record for nCPAP Prong, #5 w/ Pressure Port Elbow is GaleMed (Xiamen) Co., Ltd..
What is the Primary UDI-DI identifier for nCPAP Prong, #5 w/ Pressure Port Elbow?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06923980114311.
What classification code is assigned to this device?
This device is registered under product classification code R02010401.
Similar Classification Devices (R02010401)
Other Devices by GaleMed (Xiamen) Co., Ltd.
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