Sapphire 602-0045

GUDID B14360200451

Standard accessory kit included with Sapphire Starter Kit

Cleveland Medical Devices Inc.

Electroencephalograph

• Primary Device ID: B14360200451
• NIH Device Record Key: cd86ee29-b32f-4ec2-aea9-5394e57f687f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: Sensor Kit
• Catalog Number: 602-0045
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14360200451 [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