CGS-9001

GUDID 00851725007092

Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)

NKUS LAB

Medical networking interface unit

• Primary Device ID: 00851725007092
• NIH Device Record Key: 898de94f-4e7e-459e-98fc-55e9dbbc1bb9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CGS-9001
• Catalog Number: CGS-9001
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851725007092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083271

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

Devices Manufactured by NKUS LAB

• 00851725007351 - Next Generation NetKonnect: 2023-06-13 NGNK audio, touch, unicast, data storage
• 00851725007115 - Next Generation NetKonnect: 2022-09-08 NGNK audio, non-touch, multicast
• 00851725007306 - Next Generation NetKonnect: 2022-09-08 NGNK audio, non-touch, unicast
• 00851725007313 - Next Generation NetKonnect: 2022-09-08 NGNK no-audio, non-touch, unicast
• 00851725007320 - Next Generation NetKonnect: 2022-09-08 NGNK audio, touch, unicast
• 00851725007337 - Next Generation NetKonnect: 2022-09-08 NGNK no-audio, non-touch, multicast
• 00851725007344 - Next Generation NetKonnect: 2022-09-08 NGNK no-audio, touch, unicast
• 00851725007269 - Remote Network Station: 2021-10-08 No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer SW 02-18 unicast