Oxygen Filter

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Oxygen Filter FDA UDI
Generic Name: Respirator filter/cartridge, particulates FDA UDI
Device Name: EverFlo Kit containing (1) BF1001 and (1) BF516 FDA UDI
Model / Reference: BF1001KIT FDA UDI
Description: EverFlo Kit containing (1) BF1001 and (1) BF516 FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530104924 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

Yes

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: Respirator filter/cartridge, particulates

Oxygen Filter by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bacteria Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.

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 d5f6fbfe-2503-496d-855c-456d556f56da 34 fields · synced Jun 1, 2026