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: Pressure Regulator Part MC29D-612 5.5, Philips EverFlo, DeVilbiss 525D, Invacare 10 Liter, Perfecto2 V FDA UDI
Model / Reference: RP019 FDA UDI
Description: Pressure Regulator Part MC29D-612 5.5, Philips EverFlo, DeVilbiss 525D, Invacare 10 Liter, Perfecto2 V FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530105495 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 d83dea07-64d5-4b52-860d-0ed748995da8 34 fields · synced Jun 8, 2026