gudid
Primary ID: 6450-JP
PHONATORY AERODYNAMIC SYSTEM (UDI 6450-JP)
Manufactured by PENTAX OF AMERICA, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PHONATORY AERODYNAMIC SYSTEM - Primary ID 6450-JP
Device Regulatory Overview
The PHONATORY AERODYNAMIC SYSTEM (Model/Catalog Number: 6450-JP) is a medical device manufactured by PENTAX OF AMERICA, INC.. This product is indexed under FDA Product Code / Category Classification KLX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 6450-JP
- Product Code / EMDN
- KLX
- Device Name
- NASOMETER II (JAPAN)
- Database Sync Date
- 2026-08-09 09:46:01
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 PHONATORY AERODYNAMIC SYSTEM?
The registered manufacturer of record for PHONATORY AERODYNAMIC SYSTEM is PENTAX OF AMERICA, INC..
What is the Primary UDI-DI identifier for PHONATORY AERODYNAMIC SYSTEM?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6450-JP.
What classification code is assigned to this device?
This device is registered under product classification code KLX.
Similar Classification Devices (KLX)
Other Devices by PENTAX OF AMERICA, INC.
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