SleepView Starter Kit 700-0011-11

GUDID B1437000011112

SleepView International Starter Kit

Cleveland Medical Devices Inc.

Electroencephalograph

• Primary Device ID: B1437000011112
• NIH Device Record Key: 7347c9d7-7156-44a4-a611-bebaa230fcd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepView Starter Kit
• Version Model Number: International
• Catalog Number: 700-0011-11
• 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	B1437000011112 [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 [SleepView Starter Kit]

• B143700001192: Custom SleepView Starter Kit configuration for ProAct
• B143700001172: SleepView Consignment Kit to be used for evaluation.
• B1437000011112: SleepView International Starter Kit
• B1437000011102: SleepView Rental Starter Kit including 15 premium study kits