CO-Pilot™ Wireless Handheld Multi-Parameter System

GUDID 00849686051063

SP- BLE sensor lock, 2 pack

NONIN MEDICAL, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00849686051063
• NIH Device Record Key: bf57da0f-a0ae-41e1-9065-c7fe82241222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO-Pilot™ Wireless Handheld Multi-Parameter System
• Version Model Number: H500-SP-BLE sensor lock
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849686051063 [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

On-Brand Devices [ CO-Pilot™ Wireless Handheld Multi-Parameter System]

• 00849686051056: Data Kit
• 00849686050974: Replacement Kit
• 00849686051063: SP- BLE sensor lock, 2 pack
• 00849686051049: Power supply
• 00849686051032: Carrying Case