DreamStation 2 Kit: 4 reusable, 20 disposable

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name: DreamStation 2 Kit: 4 reusable, 20 disposable FDA UDI
Generic Name: CPAP/BPAP unit ambient air filter, single-use FDA UDI
Device Name: 4 CF1012F DreamStation 2 Compatible Reusable Filters 20 CF1012 DreamStation 2 Compatible Disposable Filters FDA UDI
Model / Reference: AUSE001DS2L FDA UDI
Description: 4 CF1012F DreamStation 2 Compatible Reusable Filters 20 CF1012 DreamStation 2 Compatible Disposable Filters FDA UDI

Identifiers

Primary DI / UDI-DI: 00848530101978 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

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

DreamStation 2 Kit: 4 reusable, 20 disposable by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 ac6e26d9-5156-46f0-8944-bf2402e24d1d 34 fields · synced Jun 6, 2026