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SomnoStar 31759-001

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846446066050 UDI-DI Date10 Aug 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SomnoStar
Generic Name
Home-use sleep apnoea recording system
Model / Ref / Catalog
31759-001
Primary DI / UDI-DI
10846446066050
510(k) Number
FDA Product Code
OLV
GMDN Term
Home-use sleep apnoea recording system
Device Class
Class II
Regulation Number
882.1400
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K012085)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Manufacturing Date

Other properties (13)

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