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Night Shift

FDA UDI

Class II (US FDA UDI)

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
Night Shift FDA UDI
Generic Name
Behavioural therapy electrical stimulation system FDA UDI
Device Name
Night Shift Device Kit (Rev 3) FDA UDI
Model / Reference
NS27-1005, NS27-1006 FDA UDI
Description
Night Shift Device Kit (Rev 3) FDA UDI

Identifiers

Primary DI / UDI-DI
10851113007939 FDA UDI
510(k) Number
K140190 FDA UDI
FDA Product Code
MYB FDA UDI
MNR FDA UDI
GMDN Term
Behavioural therapy electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
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

Yes

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

Category: Behavioural therapy electrical stimulation system

Night Shift by Advanced Brain Monitoring, 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

K140190 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Brain Monitoring, Inc.

Sources (1)

  • FDA UDI e53643df-5fb9-43b7-9fe1-a3de1a3625d3 35 fields · synced Jun 8, 2026