Sapphire 502-0170

GUDID B14350201700

LifeSense Serial Interface cable for use with Sapphire PSG system

Cleveland Medical Devices Inc.

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• Primary Device ID: B14350201700
• NIH Device Record Key: ed2bc61f-5fb8-49a3-a96a-e07671257e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: LifeSense to Sapphire Serial Cable
• Catalog Number: 502-0170
• 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: 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	B14350201700 [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: 2017-03-23

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