Model 8500 Handheld Pulse Oximeter

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Terminated Z-1690-2017 FDA Class II ·initiated 29 Sep 2016

  Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.

Trade Name

Model 8500 Handheld Pulse Oximeter EUDAMED

Handheld Pulse Oximeter GUDID

Generic Name

Pulse oximeter

Model / Reference

MODEL 8500 EUDAMED

8000AA PULSE OXIMETER EUDAMED

113303-001 EUDAMED

8500 GUDID

PULSE OXIMETER GUDID

Primary DI / UDI-DI

00849686051698

Basic UDI-DI

B-00849686051698

FDA Product Code

DQA

EMDN Code

C900301 Pulse oximeter sensors

GMDN Term

Pulse oximeter

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

870.2700

Market of Registration

Netherlands

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

EUDAMED SRN

US-MF-000008228

Authorised representative

MPS Medical Product Service GmbH DE-AR-000005009

Category: Pulse oximeter probe, single-use

• Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

  Class II

  FDA 510(k) K172625 Active Cleared 11 May 2018

• Universal Oximetry System

  Class IIb

  CE/MDD

• Nonin 6500MA

  Class II

  GUDID on market

• Nonin 9600NC-6

  Class II

  GUDID on market

• Nonin X-100EC-1

  Class II

  GUDID on market

• Nonin 8004CB

  Class II

  GUDID on market

See all devices from Nonin Medical, Inc. →

• Is the Model 8500 Handheld Pulse Oximeter designed for reusable use in clinical settings, or is it intended for single-use only?

  The Model 8500 Handheld Pulse Oximeter is explicitly designed for single-use applications in non-sterile environments like emergency medical services, homecare, or pre-hospital care. The device is classified as non-reusable (REUSABLE: 0) and is not intended for reprocessing or reuse, as confirmed by its specifications.

• What types of body locations can the Model 8500 Handheld Pulse Oximeter be used on, and how does it measure oxygen saturation?

  The Model 8500 uses photoplethysmography to measure oxygen saturation (SpO₂) and pulse rate by placing a sensor on a patient’s finger, toe, or earlobe. It continuously monitors arterial oxygen levels and heart rate in real-time, providing physiological data for clinical assessment without invasive procedures.

• What are the key wavelengths and power outputs used by the Model 8500 Handheld Pulse Oximeter, and how does this affect its functionality?

  The device employs 660 nm (red) and 910 nm (infrared) wavelengths to measure blood oxygenation and pulse rate. The maximum average output powers are 0.8 mW for red and 1.2 mW for infrared, ensuring accurate and reliable readings through non-invasive light absorption analysis in tissue.

• How is the Model 8500 Handheld Pulse Oximeter distributed, and what unique device identifier (UDI) should buyers reference when ordering?

  The Model 8500 is distributed under the UDI B-00849686051698 (with associated UDI-DI data). Buyers should reference this identifier for traceability and compliance, as it aligns with the device’s regulatory submission and global market distribution through authorized distributors like MPS Medical Product Service GmbH.

• Is the Model 8500 Handheld Pulse Oximeter compatible with all sensor types, or does it require specific sensors for accurate readings?

  The Model 8500 is intended for use with compatible sensors as specified in Nonin’s documentation. While the device itself is non-reusable, the sensors may vary in design or attachment method, so clinicians should confirm compatibility with Nonin’s guidelines to ensure accurate SpO₂ and pulse rate measurements.