Keypoint 9033S0628

GUDID 00382830050302

Review Software (Single User)

NATUS MANUFACTURING LIMITED

Electromyograph

• Primary Device ID: 00382830050302
• NIH Device Record Key: ecd4cfea-bbbb-48d3-b61a-da9fde801984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keypoint
• Version Model Number: 9033S0628
• Catalog Number: 9033S0628
• Company DUNS: 896421240
• Company Name: NATUS MANUFACTURING 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: 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	00382830050302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944547

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2019-03-28
• Device Publish Date: 2019-03-20

On-Brand Devices [Keypoint]

• 00382830053280: Electr. input connector, 5p DIN 10 cm cable
• 00382830051101: Keypoint.NET
• 00382830051095: Network Connection for Keypoint System
• 00382830051088: Movement Related Potentials
• 00382830051071: Visual Evoked Potentials
• 00382830051064: Macro EMG
• 00382830051057: Single Fiber EMG
• 00382830051040: RR-Analysis
• 00382830051033: Somatosensory Evoked Potentials
• 00382830051026: Auditory Evoked Potentials
• 00382830051019: EMG Monitor, Spectrum Analysis
• 00382830051002: EMG Monitor for Keypoint.NET
• 00382830050999: VIR SOFTWARE, EDX - EMG/ NCS
• 00382830050982: KPNET v2.2x Upgrade
• 00382830050975: M Response Analysis for Keypoint.NET
• 00382830050968: Quantitative EMG for Keypoint.NET
• 00382830050852: KeypointNET Software 2.40
• 00382830050760: 4-ch. Amplifier
• 00382830050487: 3-ch. Focus Amplifier
• 00382830050470: Hush Yoke cable, 4 meter
• 00382830050449: Multi CC Stim
• 00382830050432: Single CC Stim
• 00382830050425: Tendon Hammer
• 00382830050418: Tubal Insert Earphones
• 00382830050401: Calibrated Headset
• 00382830050395: 8-ch. Amplifier
• 00382830050388: 6-ch. EP Amplifier
• 00382830050371: 6-ch. Amplifier
• 00382830050340: Review Software (10+ Users Floating License)
• 00382830050333: Review Software (10 Users Floating License)
• 00382830050326: Review Software (5 Users Floating License)
• 00382830050302: Review Software (Single User)
• 00382830050296: Focus Main Unit
• 00382830050081: Keypoint Focus Workstation
• 00382830050043: Keypoint Focus Notebook System
• 00382830049955: Keypoint Focus Module
• 00382830049849: Natus Pattern Stimulator 22' TFT Display with Connection Kit
• 00382830049788: Keypoint G4 (Workstation)
• 00382830049665: Active Handgrip, One button model
• 00382830049450: Keypoint Focus Main Unit
• 00382830049214: Demo HaspKey (USB Dongle)
• 00382830049160: Isolating Transformer, 230V
• 00382830049153: Isolating Transformer, 115V
• 00382830049139: 3-ch. Amplifier
• 00382830049122: AMPLIFIER ARM, SINGLE
• 00382830049078: Goggles for VEP including 5m Cable
• 00382830049061: Advanced Stimulation Handgrip
• 00382830048347: Electrode cable 13P87
• 00382830048033: Electrode cable 32" red, clip x 1.5mm
• 00382830047920: HUSH bar electrode