eudamed_udi
Primary ID: 00817131020513
Inogen Rove 6 (UDI 00817131020513)
Manufactured by Inogen, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Inogen Rove 6 - Primary ID 00817131020513
Device Regulatory Overview
The Inogen Rove 6 (Model/Catalog Number: IS-501) is a medical device manufactured by Inogen, Inc.. This product is indexed under FDA Product Code / Category Classification Z12159004 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- IS-501
- Product Code / EMDN
- Z12159004
- Device Name
- Inogen Portable Oxygen Concentrators
- Database Sync Date
- 2026-08-09 16:28:50
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 Inogen Rove 6?
The registered manufacturer of record for Inogen Rove 6 is Inogen, Inc..
What is the Primary UDI-DI identifier for Inogen Rove 6?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00817131020513.
What classification code is assigned to this device?
This device is registered under product classification code Z12159004.
Similar Classification Devices (Z12159004)
Other Devices by Inogen, Inc.
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