Skip to content

Edan Instruments, Inc. devices, product family

by Edan Instruments, Inc.and 1 other manufacturer record 12 variants Basic UDI-DI 69444138SSG8

Shared by every variant

Manufacturer
Edan Instruments, Inc.(8)Edan Instruments,Inc.(4)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI
69444138SSG8
Risk class
Class IIClass IIb (varies)
Legislation
MDR
EMDN category
MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIESVITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
Market status
12 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 69444138SSG8.

Recalls

4 recalls · 3 ongoing · FDA

  • Z-1149-2026 Class II · ongoing · 24 Oct 2025
    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
  • Z-1145-2026 Class II · ongoing · 24 Oct 2025
    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
  • Z-1148-2026 Class II · ongoing · 24 Oct 2025
    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
  • Z-2388-2016 Class II · terminated · 23 Jun 2016
    Incorrect CO2 readings with some patient monitors.

Recalls matched to the 12 devices listed on this page; other pages of the family can carry others.

Variants

12 devices · page 1 of 1

Variants of Edan Instruments, Inc. devices, Basic UDI-DI 69444138SSG8
UDI-DISize and differences
NA SpO Sensor（Single-patient use）- Infant
Edan Instruments, Inc.
SpO Sensor（Single-patient use）- Infant06944413805453
Single use: yes
On the market
NA SpO Sensor（Single-patient use）- Neonatal
Edan Instruments, Inc.
SpO Sensor（Single-patient use）- Neonatal06944413805446
Single use: yes
On the market
SpO2 sensor
Edan Instruments,Inc.
01.57.47174606944413805477 —On the market
SpO2 sensor
Edan Instruments,Inc.
SH106944413805309 —On the market
SpO2 sensor
Edan Instruments,Inc.
SH31D70106944413837973 —On the market
SpO2 sensor
Edan Instruments,Inc.
SH506944413837713 —On the market
SPO2 Sensor SH1
Edan Instruments, Inc.
SH106944413810846
Single use: yes
On the market
SpO2 Sensor SH5 pediatric Silicone Soft-tip
Edan Instruments, Inc.
SH5 pediatric Silicone Soft-tip06944413805385
Single use: no
On the market
SpO2 Sensor SHD-A, adult, disposable
Edan Instruments, Inc.
SHD-A , adult, disposable06944413805439
Single use: yes
On the market
SpO2 Sensor SHD-N, Neonate, disposable
Edan Instruments, Inc.
SHD-N, Neonate, disposable06944413805408
Single use: yes
On the market
SpO2 Sensor SHD-P, pediatric, disposable
Edan Instruments, Inc.
SHD-P, pediatric, disposable06944413805422
Single use: yes
On the market
SpO2 Sensor SpO2 Finger Sensor, adult, 1m, reusable
Edan Instruments, Inc.
SpO2 Finger Sensor, adult, 1m, reusable06944413805323
Single use: no
On the market