X SERIES

GUDID 00847946029708

MAIN ASSY, X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, SPO2, SPCO, SPMET, SPHB, SPOC PVI, PI (RAINBOW), BVM/TEMP, CPR EXTENDED INSTALLED (DEMO, NOT FOR CLINICAL USE)

Zoll Medical Corporation

Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator
Primary Device ID00847946029708
NIH Device Record Key82df52b5-81ae-45eb-a8e3-8002573f2076
Commercial Distribution StatusIn Commercial Distribution
Brand NameX SERIES
Version Model Number630-2271111-01-68
Company DUNS055363428
Company NameZoll Medical Corporation
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

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Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]
GS100847946029708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive
DXNSystem, measurement, blood-pressure, non-invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [X SERIES]

00847946099657Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, TEM
00847946099558Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099541Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099534Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099497Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, PACING, NIBP, SPO2,
00847946099442Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NI
00847946099404Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, ETCO2, DMST
00847946099398Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099374MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACING, SPO2, CPR EXPANSION PACK, DMST
00847946099299MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LD, NIBP, SPO2, SPCO, SPMET, CPR EXTENDED, DMST
00847946099282MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD, PACING, NIBP, SPO2, ETCO2, DOMESTIC
00847946026462Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING ,NELLCOR, 3/5 LEAD, SPO2, NIBP, IBP/TEMP,
00847946026455Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP, CPR E
00847946026325Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, C
00847946024451Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EX
00847946024383Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946024314Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NI
00847946024260Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NO NIBP, SPO2, ETCO2,
00847946024253MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, E
00847946023614DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, CPR EXPANSION PACK AND
00847946023607DEVICE IDENTIFIER,X SERIES, ALS, 12 LD, PACE, NELLCOR, SPO2, SPCO, SPMET, ETCO2, IBP/TEMP, NIBP,
00847946023591DEVICE IDENTIFIER,X SERIES, ALS, 12 LD, PACE, NELLCOR, SPO2, SPCO, SPMET, ETCO2, TEMP, NIBP, CPR
00847946023584DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, CPR., DMST
00847946023577DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, CPR EXPANSION PACK AND
00847946023560DEVICE IDENTIFIERX SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP
00847946023553DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP
00847946020538MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, W/PACING, SPO2, ETCO2, IBP, NIBP, CPR EXPANS
00847946020514X SERIES MONITOR/DEFIBRILLATOR W/PACING,VOICE,12 LEAD W/INTERP, SPO2, NIBP, CPR EXPANSION PACK,
00847946020507MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, TEMP, CPR EXPANSION PACK
00847946020491MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, SPH
00847946020484MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, IBP
00847946020477MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EXPANS
00847946020460X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION P
00847946020453MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, CPR EXPANSION PA
00847946020446X SERIES, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, NIBP, TEMP, CPR EXPANSION PACK,
00847946020439MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACING, NIBP, SPO2, IBP/TEMP, CPR EXPANSION
00847946020422Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, CPR
00847946020385MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, DMST, REFURB
00847946020309Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP MOD-G, SPO2, AND
00847946020286Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP,
00847946020279Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NO NIBP, SPO2
00847946020262Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, CPR DASHBOARD, DMST
00847946020255Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, CPR EXPAN
00847946020248Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020231Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020149Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020132Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020019Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, DMST
00847946019990Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946019983Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, DMST

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