SleepView Starter Kit 700-0011-11

GUDID B1437000011112

SleepView International Starter Kit

Cleveland Medical Devices Inc.

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