Compumedics Neuvo 8022-0001-01

GUDID 09342451001078

LTM Module Assembly- Neuvo

COMPUMEDICS LIMITED

Electroencephalograph

Primary Device ID	09342451001078
NIH Device Record Key	497d1614-6654-45c9-bbff-f0d49e01b18a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Compumedics Neuvo
Version Model Number	Neuvo LTM Module Assembly
Catalog Number	8022-0001-01
Company DUNS	753750967
Company Name	COMPUMEDICS LIMITED
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	true
Manufacturing Date	true
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

Customer Support Contacts

Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au
Phone	+61384207386
Email	support@compumedics.com.au

Operating and Storage Conditions

Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K081151

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	4
Public Version Date	2021-04-27
Device Publish Date	2016-10-27

On-Brand Devices [Compumedics Neuvo]

09342451001207	Cable Assembly, LTM to Amplifier , NEMO - 10m
09342451001184	Dual Headbox Bracket, Neuvo System Mounting Kits (AC376)
09342451001177	Neuvo Headbox 128Ch - Wall Column Kit
09342451001160	Cable - Neuvo Control Unit, 2 meters
09342451001153	LTM Harness Cover
09342451001146	Bracket - System Unit Neuvo System Mounting Kits
09342451001139	Bracket Event Button - Neuvo Base Trolley and Wall Column
09342451001122	Bracket - LTM Headbox - Neuvo System Mounting Kits
09342451001115	Bracket - Headbox, Neuvo System Mounting Kits
09342451001108	Bracket - Headbox Mount
09342451001092	Neuvo Headbox Assembly
09342451001085	Neuvo System Unit Assembly
09342451001078	LTM Module Assembly- Neuvo
09342451001061	Neuvo Headbox (Amplifier) 64 Ch - Wall Column Kit
09342451001054	Neuvo System Unit Assembly - no HDD
09342451001047	LTM Module - Neuvo
09342451001030	Neuvo Event Button V2
09342451001023	Neuvo Wall Mount Assembly
09342451001016	System-Neuvo Wall Mnt 64 Ch LTM