8000Q2 Reusable Ear Clip Pulse Oximetry Sensor 114239-001

GUDID 00849686050936

EAR CLIP SENSOR FOR 3150

NONIN MEDICAL, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00849686050936
• NIH Device Record Key: 2d4a480b-27e0-4c88-ae45-2fe43d77a9b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8000Q2 Reusable Ear Clip Pulse Oximetry Sensor
• Version Model Number: 8000Q2
• Catalog Number: 114239-001
• 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	00849686050936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080255

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

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