Natus

GUDID 00382830003155

AUDITORY STIMULATION HEADPHONES FOR XLTEK XCALIBUR

XLTEK

Electromyograph

• Primary Device ID: 00382830003155
• NIH Device Record Key: c5f45975-c0c1-4a58-93c5-e7efb0af998e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 104037
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830003155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052112

FDA Product Code

• IKN: Electromyograph, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Natus]

• 00382830047289: Natus Quantum II Breakout B
• 00382830047272: Natus Quantum II Breakout Main
• 00382830047265: Natus Quantum II Base Unit
• 00382830047258: Natus Brain Monitor
• 00382830047210: NeuroWorks/SleepWorks 9.0.1 Installation Media (US)
• 00382830047135: Natus Quantum 64-channel Breakout
• 00382830043779: Trex HD Headbox Monitoring
• 00382830043762: EMU40 BATTERY PACK ENCLOSURE W
• 00382830043397: NATUS PHOTIC STIM
• 00382830043380: NeuroWorks TrexHD Monitoring Software Installation Media (US)
• 00382830042147: NEUROWORKS/SLEEPWORKS 8.1.1 DVD (US)
• 00382830042123: NEUROWORKS/SLEEPWORKS 8.1.0 DVD (INTL)
• 00382830041928: EMGWorks for XCalibur DVD
• 00382830041904: EP WORKS for Protektor(16) DVD
• 00382830041898: Neuroworks Sleepworks 6.1 DVD
• 00382830022309: Neuroworks/Sleepworks 8.1.0 (International) software
• 00382830022286: EP WORKS for Protektor32 DVD
• 00382830022279: Neuroworks/Sleepworks 8.1.1 GMA3 US DVD
• 00382830022262: Neuroworks/Sleepworks 8.1.0 GMA3 Int'l DVD
• 00382830022255: NEUROWORKS 8.0.1 US DVD
• 00382830022248: NEUROWORKS 8.0.0 INTL DVD
• 00382830022224: NEUROWORKS 7.1.0 INTL DVD
• 00382830020923: P32-STIM POD 2 (A-D)-20' (CR)
• 00382830020916: P32-STIM POD 1 (E-H)-20' (CR)
• 00382830020909: P32-STIM POD 1 (A-D)-20' (CR)
• 00382830020886: P32 ACQ POD 3 - 20'
• 00382830020862: P32 ACQ Pod 1 - 20'
• 00382830020855: P32-STIM POD 2 (E-H)-10' (CR)
• 00382830020848: P32 - STIM POD 2 (A-D) - 10'
• 00382830020831: P32-STIM POD 1 (E-H)-10' (CR)
• 00382830020817: P32 ACQ POD 4 - 10' (CR)
• 00382830020787: P32 ACQ POD 1 - 10'
• 00382830020770: P32 - TCMEP Pod (Cr)
• 00382830020763: Probe Pod - P32 (Cr)
• 00382830020756: P32-STIM POD 2 (E-H)-20' (CR)
• 00382830019231: NEUROWORKS 8.1.1 SOFTWARE (US)
• 00382830019194: EMU128 Breakout Box
• 00382830019187: EMU128 Mini Breakout D (Green)
• 00382830019170: EMU128 Mini Breakout C (Red)
• 00382830019163: EMU128 Mini Breakout B (Yellow)
• 00382830019101: NATUS PHOTIC STIM KIT, NO INTERFACE CABLE
• 00382830016766: Bulk Connector Pin Box Assy 8
• 00382830016759: Bulk Connector Pin Box Assy 7
• 00382830016742: Bulk Connector Pin Box Assy 6
• 00382830016735: Bulk Connector Pin Box Assy 5
• 00382830016728: Bulk Connector Pin Box Assy 4
• 00382830016711: Bulk Connector Pin Box Assy 3
• 00382830016704: Bulk Connector Pin Box Assy 2
• 00382830016698: Bulk Connector Pin Box Assy 1
• 00382830016643: Connex/Brain Monitor Breakout Box