Xltek

GUDID 00382830048255

NeuroWorks/SleepWorks 9.1.1 Software (US)

XLTEK

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

• Primary Device ID: 00382830048255
• NIH Device Record Key: cebd9599-cfcd-46f7-9524-98cd6c1757a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xltek
• Version Model Number: 024497
• Company DUNS: 245258280
• Company Name: XLTEK
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830048255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180421

FDA Product Code

• OMA: Amplitude-Integrated Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [Xltek]

• 00382830048651: P32 - STIM EXT 2 (A-D) - 9'
• 00382830048293: NeuroWorks/SleepWorks 9.2.1 Software (US)
• 00382830048279: NeuroWorks/SleepWorks 9.2.0 Software (INTL)
• 00382830048255: NeuroWorks/SleepWorks 9.1.1 Software (US)
• 00382830048231: NeuroWorks/SleepWorks 9.1.0 Software (INTL)
• 00382830047111: TrexHD/Quantum II External Battery Pack
• 00382830046350: P32 ACQ Extension cable 4 - 9'
• 00382830046343: P32 ACQ Extension Cable 3 - 9'
• 00382830046336: P32 ACQ Extension cable 2 - 9'
• 00382830046329: P32 ACQ Extension cable 1 - 9'
• 00382830046312: P32-STIM POD 2 (E-H) - 1'
• 00382830046305: P32 STIM POD 2 (A-D) - 1
• 00382830046299: P32-STIM POD 1 (E-H) - 1'
• 00382830046282: P32-STIM POD 1 (A-D) - 1'
• 00382830046275: P32 ACQ POD 4 - 1'
• 00382830046268: P32 ACQ POD 3 - 1'
• 00382830046251: P32 ACQ POD 2 - 1'
• 00382830046244: P32 ACQ POD 1 - 1'
• 00382830046237: P32 - STIM Extension cable 2 (E-H) - 19'
• 00382830046220: P32 - STIM Extension cable 2 (A-D) - 19'
• 00382830046213: P32 - STIM Extension cable 1 (E-H) - 19'
• 00382830046206: P32 - STIM Extension cable 1 (A-D) - 19'
• 00382830046190: P32 - STIM Extension cable 2 (E-H) - 9'
• 00382830046176: P32 - STIM Extension cable 1 (E-H) - 9'
• 00382830046169: P32 - STIM Extension cable 1 (A-D) - 9'
• 00382830043878: P32 ACQ Extension cable 4 - 19'
• 00382830043861: P32 ACQ Extension Cable 3 - 19'
• 00382830043854: P32 ACQ Extension cable 2 - 19'
• 00382830043847: P32 ACQ Extension cable 1 - 19'
• 00382830022231: NEUROWORKS 7.1.1 US DVD
• 00382830061766: NeuroWorks/SleepWorks 10.0.1 Installation Media (US)
• 00382830061742: NeuroWorks/SleepWorks 10.0.1 Software (US)
• 00382830059541: NeuroWorks/SleepWorks 9.3.1 Software (US)
• 00382830063067: NeuroWorks/SleepWorks 9.3.1 Installation Media (US)
• 00382830057585: XactTrace Belt 65.6ft/20m
• 00382830047425: EEG32U