X-Series

GUDID 00851113007840

X24 Stat Device kit - Dongle (PAN 1026)

ADVANCED BRAIN MONITORING, INC.

Electroencephalograph

Primary Device ID	00851113007840
NIH Device Record Key	920242f1-976d-4448-b7cc-46a0161633a1
Commercial Distribution Status	In Commercial Distribution
Brand Name	X-Series
Version Model Number	XS30-1002, XS30-1003
Company DUNS	969842715
Company Name	ADVANCED BRAIN MONITORING, 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	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

Operating and Storage Conditions

Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 7 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851113007840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131383

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	2018-07-06
Device Publish Date	2017-08-11

On-Brand Devices [X-Series]

00851113007925	X24 Stat Device Kit - ESU (PAN 1026A)
00851113007918	External Syncing Unit - Multi-Channel Kit (PAN 1026A)
00851113007895	X24 Disposable Sensor Kit
00851113007888	X10 Disposable Sensor Kit
00851113007871	Disposable AgCl Sensors
00851113007864	External Battery Custom Cable Kit X10, X24
00851113007857	X10 Stat Device Kit (PAN 1026)
00851113007840	X24 Stat Device kit - Dongle (PAN 1026)
00851113007345	X24 Stat Device Kit - ESU
00851113007819	Medium Strip Kit
00851113007802	Small Strip Kit
00851113007796	X-Small Strip Kit
00851113007628	X24 Stat Device Kit - ESU
00851113007611	X10 Stat Device Kit
00851113007697	X10 Disposable Sensor Kit
00851113007680	10-20 Medium Strip Kit
00851113007673	10-20 Small Strip Kit
00851113007666	10-20 X-Small Strip Kit
00851113007659	Medium Strip Kit
00851113007642	Small Strip Kit
00851113007635	X-Small Strip Kit
00851113007604	Linked Mastoid Cable Kit
00851113007598	Device Neoprene Strap
00851113007512	X24 Disposable Sensor Kit
00851113007505	10-20 Strip Kit Medium
00851113007499	10-20 Strip Kit Small
00851113007482	10-20 Strip Kit X-Small
00851113007406	External Syncing Unit - Multi-Channel Kit
00851113007468	X-Series Dual Lead Cable 20" Kit
00851113007451	Synapse Cream Kit
00851113007444	EEG Foam Kit
00851113007420	External Battery USB Custom Cable
00851113007413	Linked Mastoid Cable Kit
10851113007366	OSFA Strap
00851113007352	Headset Neoprene Strap
00850015266348	X24 Stat System Kit Clinical
00850015266331	Medium 10-20 Single-Use Strip Kit (Qty 5)
00850015266324	Small 10-20 Single-Use Strip Kit (Qty 5)
00850015266317	Medium 10-20 Single-Use Strip Kit
00850015266300	Small 10-20 Single-Use Strip Kit
00850015266294	Medium 10-20 Single-Use Strip
00850015266287	Small 10-20 Single-Use Strip
00850015266409	Disposable Foam Sensors (Qty 252)
00850015266423	X-Small 10-20 Single-Use Strip Kit (Qty 2)
00850015266416	X-Small 10-20 Single-Use Strip
00850015266652	X-Small 10-20 Single-Use Strip Kit (Qty 2 No Sensors)
00850015266645	Medium 10-20 Single-Use Strip Kit (No Sensors)
00850015266638	Small 10-20 Single-Use Strip Kit (No Sensors)
00850015266614	Single-Use Strip Sensor Kit
00850015266249	X24 LE Stat Device Kit Clinical

Trademark Results [X-Series]

Mark Image Registration \| Serial	Company Trademark Application Date
X-SERIES 97569476 not registered Live/Pending	HEBI Robotics, Inc. 2022-08-29
X-SERIES 90538436 not registered Live/Pending	Kovatch Mobile Equipment Corporation 2021-02-22
X-SERIES 88130855 not registered Live/Pending	DLX Enterprises, LLC 2018-09-25
X-SERIES 88044680 5666780 Live/Registered	Technology Applications, Inc. 2018-07-19
X-SERIES 87696948 5746587 Live/Registered	Thermogenesis Corp. 2017-11-26
X-SERIES 86839594 5418720 Live/Registered	RBZ Vineyards, LLC 2015-12-04
X-SERIES 86687061 5032987 Live/Registered	Infrared Systems Group, LLC 2015-07-08
X-SERIES 86435228 not registered Dead/Abandoned	Medline Industries, Inc. 2014-10-27
X-SERIES 86206543 4710702 Live/Registered	Rock River Arms, Inc. 2014-02-27
X-SERIES 86017525 4611037 Live/Registered	MTD Products Inc 2013-07-23
X-SERIES 85842070 4623214 Live/Registered	Nord-Lock International AB 2013-02-06
X-SERIES 85723812 4331714 Dead/Cancelled	Karcher North America, Inc. 2012-09-07