Prefense EDNS-9001

GUDID 00851725007023

Prefense - Early Detection and Notification System (PC)

NKUS LAB

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00851725007023
• NIH Device Record Key: d210c6e7-1217-43a1-b5ab-3141f112eb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prefense
• Version Model Number: EDNS-9001
• Catalog Number: EDNS-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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *50°C non-condensing
• Storage Environment Humidity: Between 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *50°C non-condensing
• Storage Environment Humidity: Between 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *50°C non-condensing
• Storage Environment Humidity: Between 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851725007023 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-03

On-Brand Devices [Prefense]

• 00851725007030: Prefense 24" display
• 00851725007023: Prefense - Early Detection and Notification System (PC)
• 00851725007214: Prefense - Early Detection and Notification System (Vital Signs Central) PC