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Night Shift NS27-1005.LE(SWE)

by Advanced Brain Monitoring, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850063034333 UDI-DI Date8 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Night Shift
Generic Name
Behavioural therapy electrical stimulation system
Model / Reference
NS27-1005.LE(SWE)
Primary DI / UDI-DI
00850063034333
510(k) Number
FDA Product Code
MYB, MNR
GMDN Term
Behavioural therapy electrical stimulation system
Device Class
Class II
Regulation Number
872.5570, 868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K140190)

Show all (12)

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No