Next Generation NetKonnect NGNK-6803

GUDID 00851725007306

NGNK audio, non-touch, unicast

NKUS LAB

Centralized patient monitor

• Primary Device ID: 00851725007306
• NIH Device Record Key: fc779a24-d5d7-4caa-b74a-444f0564fc4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Next Generation NetKonnect
• Version Model Number: NGNK-6803
• Catalog Number: NGNK-6803
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851725007306 [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: 2022-09-08
• Device Publish Date: 2022-08-31

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