Xhibit 96501

GUDID 10841522122996

96501,XHIBIT XC4

SPACELABS HEALTHCARE (WASHINGTON), INC

Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device ID10841522122996
NIH Device Record Key744612ad-8adb-4bd4-9586-a059e40da35a
Commercial Distribution StatusIn Commercial Distribution
Brand NameXhibit
Version Model Number96501
Catalog Number96501
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
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

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522122996 [Primary]
GS110841522122996 [Primary]
GS110841522122996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2017-09-22

On-Brand Devices [Xhibit]

10841522100345XHIBIT CENTRAL STATION,96102
10841522127069XHIBIT CENTRAL STATION,96102
10841522100536DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
1084152212299696501,XHIBIT XC4
10841522107832CENTRAL STATION,96102,LOANER
10841522107160Central Station

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