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AccuSom NS2010

by Novasom, Inc. 4 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00860512000215 UDI-DI Date21 Feb 2020ListedStatusListed GUDID: not 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  • Withdrawn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
AccuSom
Generic Name
Home-use sleep apnoea recording system
Model / Reference
NS2010
Primary DI / UDI-DI
00860512000215
GMDN Term
Home-use sleep apnoea recording system
GUDID distribution status
Not in Commercial Distribution

Other devices from Novasom, Inc.

  • Accusom

    Class II

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number

Other properties (11)

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