Xhibit N/A

GUDID 10841522107160

Central Station

SPACELABS HEALTHCARE (WASHINGTON), INC

Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device ID10841522107160
NIH Device Record Key39b9acce-6a38-4a27-b1b7-b461a9cda461
Commercial Distribution Discontinuation2016-12-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameXhibit
Version Model Number96102
Catalog NumberN/A
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522107160 [Primary]
GS110841522107160 [Primary]
GS110841522107160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA
DSIDETECTOR AND ALARM, ARRHYTHMIA
DSIDETECTOR AND ALARM, ARRHYTHMIA

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 Date2016-10-04

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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