CGS-9001

GUDID 00851725007092

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

NKUS LAB

Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit Medical networking interface unit 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

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

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

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• 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