DreamStation

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: DreamStation FDA UDI
Generic Name: Clinical laboratory information system FDA UDI
Device Name: DreamStation Nonin SpO2 Cable FDA UDI
Model / Reference: DreamStation Nonin SpO2 Cable FDA UDI
Description: DreamStation Nonin SpO2 Cable FDA UDI

Identifiers

Catalog Number: 1121694 FDA UDI
Primary DI / UDI-DI: 00606959040465 FDA UDI
510(k) Number: K081285 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Clinical laboratory information system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 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: Clinical laboratory information system

DreamStation by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical laboratory information system.

Screening Center — Wallac, Inc. · Class I
UDM (Urinalysis Data Manager) — Sysmex Corp. · Class I
WAM (Work Area Management) — Sysmex America, Inc. · Class I
Specimen Gate Laboratory — Wallac, Inc. · Class I
PTS Connect™ Universal Solution — Polymer Technology Systems · Class I
EVOYA Platform — Wallac, Inc. · Class I
PatientCare — Wallac, Inc. · Class I
DreamStation — Respironics, Inc. · Class I

Cleared under the same submission

K081285 also covers:

Nonin — Nonin Medical, Inc.

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 f520679c-2f10-4172-894a-50471a09de09 37 fields · synced Jun 7, 2026