8000R Reusable Reflectance Pulse Oximetry Sensor 114240-001

GUDID 00849686050929

FOREHEAD SENSOR FOR 3150I

NONIN MEDICAL, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00849686050929
• NIH Device Record Key: e8c21c80-6020-46e9-99ae-4c17cd18e851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8000R Reusable Reflectance Pulse Oximetry Sensor
• Version Model Number: 8000R
• Catalog Number: 114240-001
• Company DUNS: 174959692
• Company Name: NONIN MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849686050929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050056

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-23

Devices Manufactured by NONIN MEDICAL, INC.

• 00849686052367 - MODEL 3150, WRIST-OX2, BLE: 2024-11-29 MODEL 3150, WRIST-OX2, BLE
• 00849686051698 - HANDHELD PULSE OXIMETER: 2024-09-25 HANDHELD PULSE OXIMETER with 8500, PULSE OXIMETER
• 00849686065855 - HANDHELD PULSE OXIMETER: 2024-09-25 HANDHELD PULSE OXIMETER with 2500C, PULSE OXIMETER CHARGER
• 00849686066524 - Reusable Finger Clip Pulse Oximetry Sensors: 2024-09-25 Reusable Finger Clip Pulse Oximetry Sensors with 8000AA, FINGER CLIP SENSOR 1M
• 00849686070637 - RESUSABLE PULSE OXIMETRY SENSOR SYSTEM: 2024-09-25 RESUSABLE PULSE OXIMETRY SENSOR SYSTEM with 8100Q2, REUSABLE EAR CLIP SENSOR
• 00849686085976 - REUSABLE PULSE OXIMETRY SOFT SENSORS: 2024-09-25 REUSABLE PULSE OXIMETRY SOFT SENSORS, 70276 with 8000JFW ADULT FLEXW DISP
• 00833166000122 - PALMSAT HANDHELD OXIMETER: 2024-09-18 PALMSAT HANDHELD OXIMETER WITH 8000SM SENSOR
• 00833166000139 - PALMSAT HANDHELD OXIMETER: 2024-09-18 PALMSAT HANDHELD OXIMETER with 8000SM-3