Sapphire 502-0125-4

GUDID B143502012540

Wireless PSG Patient Unit for Sleep Testing

Cleveland Medical Devices Inc.

Electroencephalograph

• Primary Device ID: B143502012540
• NIH Device Record Key: 7824155d-b0ff-439b-80c8-6feb7889fe40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: Sapphire 2400 Patient Unit
• Catalog Number: 502-0125-4
• Company DUNS: 557510625
• Company Name: Cleveland Medical Devices 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: 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
HIBCC	B143502012540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042039

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Sapphire]

• B14360200451: Standard accessory kit included with Sapphire Starter Kit
• B14350201700: LifeSense Serial Interface cable for use with Sapphire PSG system
• B14350201440: SPO2 Interface cable for use with Sapphire PSG system
• B143502012540: Wireless PSG Patient Unit for Sleep Testing