gudid
Primary ID: 10-10417-00-01 (BT)
Inogen Rove 4 (UDI 10-10417-00-01 (BT))
Manufactured by Inogen, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Inogen Rove 4 - Primary ID 10-10417-00-01 (BT)
Device Regulatory Overview
The Inogen Rove 4 (Model/Catalog Number: 10-10417-00-01 (BT)) is a medical device manufactured by Inogen, Inc.. This product is indexed under FDA Product Code / Category Classification CAW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 10-10417-00-01 (BT)
- Product Code / EMDN
- CAW
- Device Name
- The Inogen Rove 4 Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 4 Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
- Database Sync Date
- 2026-08-09 09:31:22
Full Regulatory Attributes
🔒 Token Gated
{
"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 4?
The registered manufacturer of record for Inogen Rove 4 is Inogen, Inc..
What is the Primary UDI-DI identifier for Inogen Rove 4?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10-10417-00-01 (BT).
What classification code is assigned to this device?
This device is registered under product classification code CAW.
Similar Classification Devices (CAW)
Other Devices by Inogen, Inc.
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