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BluSat 4343

by OSI Optoelectronics 2 variants

BluSat 4343 is a Class II device made by OSI Optoelectronics, listed in FDA GUDID since 2 Feb 2021 (UDI-DI 10859998006320), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10859998006320 UDI-DI Date2 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
BluSat
Generic name
Pulse oximeter probe, single-use
Model / reference
4343
Primary DI / UDI-DI
10859998006320
FDA product code
DQA
GMDN term
Pulse oximeter probe, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, single-use

Similar devices in this category

Other devices filed under Pulse oximeter probe, single-use.

Other devices from OSI Optoelectronics

  • BluSat 4343

    Class II

  • Dolphin 2311

    Class II

  • Dolphin 3312-V

    Class II

  • Dolphin 2312

    Class II

See all devices from OSI Optoelectronics →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)