RNS-9703-242

GUDID 00851725007122

Remote Network Station with 24” display

NKUS LAB

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device ID00851725007122
NIH Device Record Key3a8afac3-e711-46b3-ad24-e4fab78110ac
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRNS-9703-242
Catalog NumberRNS-9703-242
Company DUNS080352293
Company NameNKUS LAB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)474-9207
Emailinfo@nklab.com
Phone+1(949)474-9207
Emailinfo@nklab.com
Phone+1(949)474-9207
Emailinfo@nklab.com
Phone+1(949)474-9207
Emailinfo@nklab.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing

Device Identifiers

Device Issuing AgencyDevice ID
GS100851725007122 [Primary]

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-06-22

Devices Manufactured by NKUS LAB

00851725007351 - Next Generation NetKonnect2023-06-13 NGNK audio, touch, unicast, data storage
00851725007115 - Next Generation NetKonnect2022-09-08 NGNK audio, non-touch, multicast
00851725007306 - Next Generation NetKonnect2022-09-08 NGNK audio, non-touch, unicast
00851725007313 - Next Generation NetKonnect2022-09-08 NGNK no-audio, non-touch, unicast
00851725007320 - Next Generation NetKonnect2022-09-08 NGNK audio, touch, unicast
00851725007337 - Next Generation NetKonnect2022-09-08 NGNK no-audio, non-touch, multicast
00851725007344 - Next Generation NetKonnect2022-09-08 NGNK no-audio, touch, unicast
00851725007269 - Remote Network Station2021-10-08 No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer SW 02-18 unicast

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.