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NightWare 100001

by Nightware, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00860005400706 UDI-DI Date15 Mar 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NightWare
Generic Name
Sleep disorder interpretive software, patient-use
Model / Reference
100001
Primary DI / UDI-DI
00860005400706
FDA Product Code
QMZ
GMDN Term
Sleep disorder interpretive software, patient-use
Device Class
Class II
Regulation Number
882.5705
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sleep disorder interpretive software, patient-use

Similar devices

Also classified as Sleep disorder interpretive software, patient-use.

Other devices from Nightware, Inc.

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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