Invacare Panel Control for PerfectO2 and PerfectO2V

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Invacare Panel Control for PerfectO2 and PerfectO2V FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: Replacement Part Invacare Panel Control for PerfectO2 and PerfectO2V OEM# 1143469 FDA UDI
Model / Reference: RP047 FDA UDI
Description: Replacement Part Invacare Panel Control for PerfectO2 and PerfectO2V OEM# 1143469 FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530107369 FDA UDI
FDA Product Code: BYX FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile/portable oxygen concentrator

Invacare Panel Control for PerfectO2 and PerfectO2V by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Mobile/portable oxygen concentrator.

SimplyGo Mini — Respironics, Inc. · Class II
SimplyGo Mini — Respironics, Inc. · Class II
SimplyGo Mini — Respironics, Inc. · Class II
FreeStyle — CAIRE INC. · Class II
DISCOV-R — BELLUSCURA PLC · Class II
GCE — GAS CONTROL EQUIPMENT LIMITED · Class II
SimplyGo Mini — Respironics, Inc. · Class II
Inogen One G2 Oxygen Concentrator — Inogen, Inc. · 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 I	Pending data

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

Manufacturer

Manufacturer: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI b8c3e66e-4c6a-4ab0-bd46-14f9ecbe31e0 34 fields · synced Jun 6, 2026