6IN HEPA Capsule with Removable Sticker

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: 6IN HEPA Capsule with Removable Sticker FDA UDI
Generic Name: Respirator filter/cartridge, particulates FDA UDI
Device Name: 6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum 5 and 10 TM, and PerfectO2TM FDA UDI
Model / Reference: CS204 FDA UDI
Description: 6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum 5 and 10 TM, and PerfectO2TM FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530104436 FDA UDI
510(k) Number: K102483 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Respirator filter/cartridge, particulates FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Respirator filter/cartridge, particulates

6IN HEPA Capsule with Removable Sticker by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Respirator filter/cartridge, particulates.

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CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II

Cleared under the same submission

K102483 also covers:

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

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Manufacturer

Manufacturer: SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

FDA UDI c79bb5bd-6517-4ece-a19a-36d2eda42ff3 35 fields · synced Jun 8, 2026