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NightBalance

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
NightBalance FDA UDI
Generic Name
Behavioural therapy electrical stimulation system FDA UDI
Device Name
Philips NightBalance, Canada FDA UDI
Model / Reference
00 FDA UDI
Description
Philips NightBalance, Canada FDA UDI

Identifiers

Catalog Number
L2US01CA FDA UDI
Primary DI / UDI-DI
00606959059597 FDA UDI
510(k) Number
K180608 FDA UDI
FDA Product Code
MYB FDA UDI
GMDN Term
Behavioural therapy electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Behavioural therapy electrical stimulation system

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

Similar devices

Also classified as Behavioural therapy electrical stimulation system.

Cleared under the same submission

K180608 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 18254302-4543-4330-b63c-40fdd62a5723 37 fields · synced May 30, 2026