CO-Pilot™ Wireless Handheld Multi-Parameter System

GUDID 00849686051094

NONIN MEDICAL, INC.

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00849686051094
• NIH Device Record Key: f3ebaed3-80c6-4e88-8ce0-f3adebb9e8fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO-Pilot™ Wireless Handheld Multi-Parameter System
• Version Model Number: H500
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00849686051094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192900

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: 2020-11-03
• Device Publish Date: 2020-10-26

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