OxyGo Fit+ Rove 4

FDA UDI

Class II (US FDA UDI)

by Inogen, Inc.

Identity

Trade Name: OxyGo Fit+ Rove 4 FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: The OxyGo Fit+ 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. FDA UDI
Model / Reference: OxyGo Fit+ (10-13401-00-01) FDA UDI
Description: The OxyGo Fit+ 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00817131020698 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile/portable oxygen concentrator

OxyGo Fit+ Rove 4 by Inogen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile/portable oxygen concentrator.

Invacare F-Tube, PVC for PerectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
SimplyGo Mini — Respironics, Inc. · Class II
SimplyGo Mini — Respironics, Inc. · Class II
SimplyGo Mini — Respironics, Inc. · Class II
FreeStyle — CAIRE INC. · Class II
Invacare Panel Control for PerfectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
DISCOV-R — BELLUSCURA PLC · Class II
GCE — GAS CONTROL EQUIPMENT LIMITED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Inogen, Inc.

Sources (1)

FDA UDI c108959e-2694-4207-9f95-7f9c9dc9951f 35 fields · synced May 31, 2026