DreamStation

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: DreamStation FDA UDI
Generic Name: Home CPAP unit FDA UDI
Device Name: DreamStation CPAP with WiFi, American Home Patient (AHP) FDA UDI
Model / Reference: DreamStation CPAP w/WiFi, AHP FDA UDI
Description: DreamStation CPAP with WiFi, American Home Patient (AHP) FDA UDI

Identifiers

Catalog Number: AHX200S11W FDA UDI
Primary DI / UDI-DI: 00606959034198 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Home CPAP unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Home CPAP unit

DreamStation by Respironics, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI d00f8963-97c8-4504-83eb-bcde214f5f71 36 fields · synced Jun 8, 2026