Repair Parts

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: REPAIR PARTS FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: Concentrator Capacitor 15MFD - Platinum Series for IRC5LX, IRC5LXO2, IRCLXAW, IRCSLXO2AW, IRC5LXO2AWQ, IRC9LXO2AP, and IRC5LXAWQ (OEM# 2003019) FDA UDI
Model / Reference: RP014 FDA UDI
Description: Concentrator Capacitor 15MFD - Platinum Series for IRC5LX, IRC5LXO2, IRCLXAW, IRCSLXO2AW, IRC5LXO2AWQ, IRC9LXO2AP, and IRC5LXAWQ (OEM# 2003019) FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530105228 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

Repair Parts by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI 63fcea4d-99be-4301-9c37-6a377349493e 34 fields · synced Jun 1, 2026