MODO A/NIH8000

GUDID 00841983103704

CART FOR EEG-9200 / EEG-1200

NIHON KOHDEN AMERICA, INC.

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• Primary Device ID: 00841983103704
• NIH Device Record Key: 183e2099-b82a-4a13-a64c-e92940f36106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODO
• Version Model Number: A/NIH8000
• Catalog Number: A/NIH8000
• Company DUNS: 021063219
• Company Name: NIHON KOHDEN AMERICA, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983103704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080546

FDA Product Code

• OLT: Non-normalizing quantitative electroencephalograph software

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: 2016-09-24

Devices Manufactured by NIHON KOHDEN AMERICA, INC.

• 10841983103947 - NA: 2023-10-09 PAPER, ECG1250, 9020, 10 PADS
• 10841983103954 - NA: 2023-10-09 PAPER, ECG1350, 9130, 10 PADS
• 10841983103930 - NA: 2023-08-17 PAPER, ECG-1550A, 10 PADS
• 00841983104336 - NK-HealthProtect Wireless Surge Solution: 2021-12-31 Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring
• 10841983102667 - NA: 2021-11-10 SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable
• 10841983102674 - NA: 2021-11-10 SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable
• 10841983102704 - BluPRO®: 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable
• 10841983102711 - BluPRO®: 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable