Sapphire PSG 2400 Starter Kit 700-0009-2

GUDID B143700000922

Sapphire PSG 2400 Starter Kit.

Cleveland Medical Devices Inc.

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

• Primary Device ID: B143700000922
• NIH Device Record Key: 5f2a5d9d-d1d8-4d0c-b623-9a61d40598d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire PSG 2400 Starter Kit
• Version Model Number: Standard
• Catalog Number: 700-0009-2
• 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	B143700000922 [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

Devices Manufactured by Cleveland Medical Devices Inc.

• B14350100280 - SleepScout: 2018-07-06 SPO2 Interface cable for use with SleepScout PSG system
• B14350101320 - SleepScout: 2018-07-06 Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
• B143502012540 - Sapphire: 2018-07-06 Wireless PSG Patient Unit for Sleep Testing
• B14350201440 - Sapphire: 2018-07-06 SPO2 Interface cable for use with Sapphire PSG system
• B143502014610 - SleepScout: 2018-07-06 Wireless portable sleep monitor for sleep testing
• B14350201490 - SleepScout: 2018-07-06 SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
• B143502016910 - SleepView: 2018-07-06 Portable Sleep Monitor for Home Sleep Testing
• B14350201700 - Sapphire: 2018-07-06 LifeSense Serial Interface cable for use with Sapphire PSG system