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Somanetics SPFB-USA

by Hygia Health Services, Inc.

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 Number10817357022190 UDI-DI Date4 Feb 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  • Withdrawn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
Somanetics
Generic Name
Tissue saturation oximeter sensor, reprocessed
Model / Reference
SPFB-USA
Primary DI / UDI-DI
10817357022190
510(k) Number
FDA Product Code
NMD
GMDN Term
Tissue saturation oximeter sensor, reprocessed
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
Not in Commercial Distribution

Other devices from Hygia Health Services, Inc.

See all devices from Hygia Health Services, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No