Oxygen Filter

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: Oxygen Filter FDA UDI
Generic Name: Anaesthesia conduction filter FDA UDI
Device Name: Healthdyne Alliance Style Foam Filters - Bulk FDA UDI
Model / Reference: OF3002NS FDA UDI
Description: Healthdyne Alliance Style Foam Filters - Bulk FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530050368 FDA UDI
FDA Product Code: JRL FDA UDI
GMDN Term: Anaesthesia conduction filter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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: Anaesthesia conduction filter

Oxygen Filter is a sterile microporous membrane used to minimize particulate contamination of local anesthetics during administration. This single-use device is designed for inpatient use and features a proprietary foam design. The oxygen filter is part of the Healthdyne Alliance Style bulk package, which includes various products for anesthesia administration.

Similar devices

Also classified as Anaesthesia conduction filter.

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Portex — ICU MEDICAL, INC. · Class II
Dash 6 — Intervene Group Limited · Class II
DeVilbiss Style Felt Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Covidien NPB 492A Style Foam Cabinet Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Covidien NPB 492A Style Foam Cabinet Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Oxygen Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I

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 4716625e-0e99-408c-8e64-e3b378856602 34 fields · synced Jul 12, 2026