Study Kit 602-0076

GUDID B14360200761

Single use study kit (compatible with thermistor).

Cleveland Medical Devices Inc.

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

Primary Device ID	B14360200761
NIH Device Record Key	7f80c549-2dd9-4d63-b166-133dd590ec62
Commercial Distribution Status	In Commercial Distribution
Brand Name	Study Kit
Version Model Number	Compatible with Thermistor - Single
Catalog Number	602-0076
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	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14360200761 [Primary]
HIBCC	B14360200772 [Package] Package: Box [10 Units] In Commercial Distribution
HIBCC	B14360200782 [Package] Package: Box [25 Units] In Commercial Distribution

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 [Study Kit]

B14360201171	Single use international study kit.
B14360200761	Single use study kit (compatible with thermistor).
B14360200751	Single