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ResMed AirSense 11 Style Filters

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
ResMed AirSense 11 Style Filters FDA UDI
Generic Name
CPAP/BPAP unit ambient air filter, single-use FDA UDI
Device Name
Resmed Airsense 11 CPAP Filter - 3/Pack FDA UDI
Model / Reference
ASUS002CF2111 FDA UDI
Description
Resmed Airsense 11 CPAP Filter - 3/Pack FDA UDI

Identifiers

Primary DI / UDI-DI
00848530103798 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

ResMed AirSense 11 Style Filters by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 ed703e63-1849-43b3-b081-7ce6c7b35ccc 34 fields · synced May 30, 2026