Alice 6

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: Alice 6 FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: Assembly, Alice 6 Base Station, LDx, China FDA UDI
Model / Reference: ALICE 6 FDA UDI
Description: Assembly, Alice 6 Base Station, LDx, China FDA UDI

Identifiers

Catalog Number: 1122301 FDA UDI
Primary DI / UDI-DI: 00606959033740 FDA UDI
FDA Product Code: OLV FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Polysomnograph

Alice 6 by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

SleepmateSnoring Microphone — Ambu A/S · Class II
Perfect Fit — Dymedix Diagnostics, Inc. · Class II
Cadwell — Cadwell Industries, Inc. · Class II
TriplePlay — Dymedix Diagnostics, Inc. · Class II
Perfect Fit — Dymedix Diagnostics, Inc. · Class II
micromed — Micromed, Inc. · Class II
Cadwell — Cadwell Industries, Inc. · Class II
Natus — Embla Systems · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI 939c1f3e-fc1c-406e-96d5-9d88489d58fe 36 fields · synced Jun 8, 2026