Next Generation NetKonnect

Basic Information

• Brand Name: Next Generation NetKonnect
• Primary DI: 00851725007313
• Version / Model: NGNK-6804
• Catalog Number: NGNK-6804
• Company Name: NKUS LAB
• Labeler DUNS: 080352293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: 6f3803ca-4e93-4956-8758-58beb98a9442

Device Description

NGNK no-audio, non-touch, unicast

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851725007313	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220989	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: non-condensing
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity