SleepScout 501-0028

GUDID B14350100280

SPO2 Interface cable for use with SleepScout PSG system

Cleveland Medical Devices Inc.

Electroencephalograph

• Primary Device ID: B14350100280
• NIH Device Record Key: 4a4baa93-6268-4457-935e-aabd36e0e6cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepScout
• Version Model Number: XPOD Interface
• Catalog Number: 501-0028
• 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	B14350100280 [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: 2016-09-26

On-Brand Devices [SleepScout]

• B14360201292: Optional accessory kit for use with SleepScout - International customers
• B14360200511: Optional accessory kit for use with SleepScout
• B14350201490: SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
• B143502014610: Wireless portable sleep monitor for sleep testing
• B14350101320: Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
• B14350100280: SPO2 Interface cable for use with SleepScout PSG system