Next Generation NetKonnect NGNK-6801

GUDID 00851725007351

NGNK audio, touch, unicast, data storage

NKUS LAB

Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00851725007351
• NIH Device Record Key: fb745315-1bbb-4520-b3c7-e10473bee631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Next Generation NetKonnect
• Version Model Number: NGNK-6801
• Catalog Number: NGNK-6801
• Company DUNS: 080352293
• Company Name: NKUS LAB
• 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(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com
• Phone: +1(949)474-9207
• Email: info@nklab.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851725007351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220989

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [Next Generation NetKonnect]

• 00851725007344: NGNK no-audio, touch, unicast
• 00851725007337: NGNK no-audio, non-touch, multicast
• 00851725007320: NGNK audio, touch, unicast
• 00851725007313: NGNK no-audio, non-touch, unicast
• 00851725007306: NGNK audio, non-touch, unicast
• 00851725007115: NGNK audio, non-touch, multicast
• 00851725007351: NGNK audio, touch, unicast, data storage