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CPAP Filter

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
CPAP Filter FDA UDI
Generic Name
CPAP/BPAP unit ambient air filter, single-use FDA UDI
Device Name
Resvent iBreeze Disposable CPAP Filter - 2/pk FDA UDI
Model / Reference
ASNU001CF9901-2 FDA UDI
Description
Resvent iBreeze Disposable CPAP Filter - 2/pk FDA UDI

Identifiers

Primary DI / UDI-DI
00850035116425 FDA UDI
FDA Product Code
JRL FDA UDI
GMDN Term
CPAP/BPAP unit ambient air filter, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CPAP/BPAP unit ambient air filter, single-use

Discover the CPAP Filter, a non-sterile, disposable airway pressure (CPAP/BPAP) unit filter designed to remove particulates and impurities from ambient air before inhalation. This single-use device is not intended for medical gas filtration and is typically installed over an existing CPAP/BPAP unit. With its easy-to-install design, this filter provides a reliable and efficient solution for patients who require CPAP treatment.

Similar devices

Also classified as CPAP/BPAP unit ambient air filter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI ea60f682-9d3e-43a3-b13b-6de1de2d7dc1 34 fields · synced Jul 2, 2026