YZ-0226

GUDID 04931921106426

ASSEMBLY KIT FOR EEG-9100A

NIHON KOHDEN CORPORATION

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

• Primary Device ID: 04931921106426
• NIH Device Record Key: e31e23c8-f0de-4130-8960-f8e99a8e7f19
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: YZ-0226
• Catalog Number: YZ-0226
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• 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: false
• 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: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931921106426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011204

FDA Product Code

• OLV: Standard polysomnograph with 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-05

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• 04931921007723 - Nihon Kohden, EEG-1200A Series Neurofax: 2023-10-09 Cart, used with EEG-1200A, works with standard and optional accessories
• 04931921007730 - Nihon Kohden, EEG-1200A Series Neurofax: 2023-10-09 Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
• 04931921017166 - CNS-2101 Central Monitor: 2023-10-09 Central Monitor
• 04931921010235 - cap-ONE: 2023-05-30 cap-ONE Nasal Adapter, Adult
• 04931921010273 - cap-ONE: 2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube
• 04931921010303 - cap-ONE: 2023-05-30 cap-ONE Nasal Adapter, Pediatric