Prefense EDNS-9001-AVGH977

GUDID 00851725007214

Prefense - Early Detection and Notification System (Vital Signs Central) PC

NKUS LAB

Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device ID00851725007214
NIH Device Record Key01127c8c-deb0-49a1-84d4-c7a4912f2ed4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrefense
Version Model NumberEDNS-9001-AVGH977
Catalog NumberEDNS-9001-AVGH977
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
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 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *50°C non-condensing
Storage Environment HumidityBetween 80 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]
GS100851725007214 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

On-Brand Devices [Prefense]

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

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