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ALICE PDx

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
ALICE PDx FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
Alice PDx Portable Sleep Diagnostic System, Japan FDA UDI
Model / Reference
Alice PDx Sleep Diagnostic System, JP FDA UDI
Description
Alice PDx Portable Sleep Diagnostic System, Japan FDA UDI

Identifiers

Catalog Number
1047990 FDA UDI
Primary DI / UDI-DI
00606959038813 FDA UDI
510(k) Number
K090484 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Cleared under the same submission

K090484 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 9e90ce5f-a259-4cd0-85f7-3b0835c9d454 38 fields · synced May 31, 2026