← Back to catalogue

RUSleeping RTS

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
RUSleeping RTS FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
RUSleeping RTS, International Model FDA UDI
Model / Reference
RUSLEEPING RTS FDA UDI
Description
RUSleeping RTS, International Model FDA UDI

Identifiers

Catalog Number
1127364 FDA UDI
Primary DI / UDI-DI
00606959029149 FDA UDI
510(k) Number
K022294 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
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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Polysomnograph

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

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K022294 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 08a57005-4697-4a68-8052-e1b0f0de14c4 37 fields · synced May 30, 2026