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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 Chest Belt Kit - Dutch FDA UDI
Model / Reference
NS27-4102(DUT) FDA UDI
Description
Night Shift Chest Belt Kit - Dutch FDA UDI

Identifiers

Primary DI / UDI-DI
00850015266096 FDA UDI
510(k) Number
K140190 FDA UDI
FDA Product Code
MNR FDA UDI
MYB FDA UDI
GMDN Term
Behavioural therapy electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

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 633dcab3-5426-4e72-8aad-accf2c4adec5 34 fields · synced Jun 8, 2026