M SERIES BIPHASIC

GUDID 00847946013387

Defibrillator ,MAIN,CCT,MANUAL-1,3/5 LEAD,SPO2,BIPHASIC,RCD,SMR,CDMK,AC,DMST,REFURB

Zoll Medical Corporation

Physiologic-monitoring defibrillation system
Primary Device ID00847946013387
NIH Device Record Key4f0d5ea0-5e22-4f4e-9e23-ed698e9a7158
Commercial Distribution StatusIn Commercial Distribution
Brand NameM SERIES BIPHASIC
Version Model Number60010211100024010
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

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946013387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-18

On-Brand Devices [M SERIES BIPHASIC]

00847946024505MAIN,ACLS/MNL-1,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,EL,DC,PC,RC,SM,CM,BLUETOOTH,ENG, REFURB
00847946019648Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, NIBP, CF/STD, DMST
00847946017736Defibrillator ,MAIN,MANUAL-1,12 LEAD CCT,SPO2,ETCO2,NIBP,BIPHASIC,PACE,RCD,SMR,CDMK,DC,DMST
00847946014766Defibrillator ,MAIN,ACLS MANUAL-1,12 LEAD,MUSE,ETCO2,SPO2,NIBP,BIPHASIC,EL,AC,PACE,RCD,SMR,CDMK,
00847946014742Defibrillator ,MAIN,MANUAL-1,12 LEAD,MUSE,SPO2,ETCO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,AC,DMST,REFUR
00847946014735Defibrillator ,MAIN,BASIC-4,12 LEAD,MUSE,SPO2,ETCO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
00847946014483Defibrillator ,MAIN,MANUAL-2,12 LEAD,MUSE,SPO2,ETCO2,BIPHASIC,EL,RCD,SMR,CDMK,AC,DMST,REFURB
00847946014476Defibrillator ,MAIN,BASIC-3,12 LEAD,MUSE,SPO2,ETCO2,BIPHASIC,EL,RCD,SMR,CDMK,AC,DMST,REFURB
00847946014469Defibrillator ,MAIN, BASIC-4, 12LEAD,SPO2,BIPHASIC,MUSE,AC,RC,PC,SM,CM,ENG,REFURB
00847946014452Defibrillator ,MAIN, MANUAL-1,12 LEAD,MUSE,AC,BIPHASIC,PACE,RCD,SMR,CDMK,DMST, REFURB
00847946014384Defibrillator ,MAIN,ACLS/MNL-1,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,EL,AC,XL,PC,RC,SM,CM,BLUETOOTH,EN
00847946014377Defibrillator ,MAIN,ACLS/MNL-1,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,EL,AC,PC,RC,SM,CM,XL,DMST,REFURB
00847946014360Defibrillator ,MAIN, EMTD-1,AED,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,DC,PC,EL,RC,SM,CM,DMST,REFURB
00847946014353Defibrillator ,MAIN,MNL-1,12 LEAD,SPO2,NIBP,ETCO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,DC,DMST,REFURB
00847946014346Defibrillator ,MAIN, EMTD-1,BLUETOOTH,12LEAD,SPO2,ETCO2,NIBP,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFU
00847946014339Defibrillator ,MAIN,EMTD-1/AED,12LEAD,SPO2,NIBP,BLUETOOTH,BIPHASIC,AC,PC,EL,RC,SM,CM,DMST, REFUR
00847946014322Defibrillator ,MAIN,ACLS,MNL-1,12LEAD,SPO2,NIBP,BIPHASIC,EL,AC,PC,RC,SM,CM,BLUETOOTH,ENG,REFURB
00847946014315Defibrillator ,MAIN,EMTD-1/AED,12LEAD,SPO2,NIBP,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB
00847946014308Defibrillator ,MAIN,MANUAL-1,12 LEAD CCT,SPO2,NIBP,BIPHASIC,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
00847946014292Defibrillator ,MAIN,ACLS,MNL-1,12LEAD,SPO2,NIBP,BIPHASIC,EL,AC,PC,RC,SM,CM,ENG,REFURB
00847946014285Defibrillator ,MAIN,BASIC-4, 12LEAD,SPO2,NIBP,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB
00847946014278Defibrillator ,MAIN,EMTD-2/AED,12LEAD,SPO2,BIPHASIC,NIBP,AC,EL,RC,SM,CM,ENG,REFURB
00847946014261Defibrillator ,MAIN,ACLS,MNL-2, 12LEAD,SP02,BIPHASIC,NIBP,AC,EL,RC,SM,CM,ENG,REFURB
00847946014254Defibrillator ,MAIN,BASIC-3,12LEAD,SPO2,NIBP,BIPHASIC,AC,EL,RC,SM,CM,ENG,REFURB
00847946014216Defibrillator ,MAIN, EMTD-1,AED,12LEAD,ETCO2,SPO2,BIPHASIC,DC,PC,EL,RC,SM,CM,ENG,REFURB
00847946014209Defibrillator ,MAIN MANUAL 1,12LEAD,ETCO2/SPO2,DC,BIPHASIC,PACE,EL,RCD,SMR,CDMK,ENG,REFURB
00847946014186Defibrillator ,MAIN MANUAL 1,12LEAD,ETCO2,SPO2,AC,BLUETOOTH.BIPHASIC,PACE,EL,RCD,SMR,CDMK,ENG,RE
00847946014179Defibrillator ,MAIN,BASIC-4,12LEAD,ETCO2,SPO2,BLUETOOTH,BIPHASIC,AC,PC,EL,RCD,SMR,CDMK,ENG,REFUR
00847946014162Defibrillator ,MAIN, EMTD-1,BIPHASIC,ETCO2,SPO2,AC,12 LEAD, AUDIO,RC,SMR,CDM, DMST, REFURB
00847946014148Defibrillator ,MAIN,MANUAL-1,12 LEAD CCT,SPO2,ETCO2,BIPHASIC,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
00847946014131Defibrillator ,MAIN,MNL-1, 12LEAD,ETCO2,SPO2,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB
00847946014124Defibrillator ,MAIN, BASIC-4, 12LEAD,ETCO2,SPO2,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB
00847946014117Defibrillator ,MAIN, EMTD-2,AED,12LEAD,ETCO2,SPO2,BIPHASIC,AC,EL,RC,SM,CDMK, DMST, REFURB
00847946014100Defibrillator ,MAIN, MANUAL-2, 12LEAD,ETCO2,SPO2,BIPHASIC,AC,EL,RC,SM,CM,ENG,REFURB
00847946014094Defibrillator ,MAIN, BASIC-3,12LEAD,ETCO2,SPO2,BIPHASIC,AC,EL,RCD,SMR,CDMK, ENG,REFURB
00847946014056Defibrillator ,MAIN, AED/SPO2 12LD,BIPHASIC, DC/PC/RCD/SMR/CDMK, REFURB
00847946014049Defibrillator ,MAIN,MAN-1,12 LEAD,SPO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,DC,DMST,REFURB
00847946014001Defibrillator ,MAIN,EMTD-1,12 LEAD,SPO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,W/VOICE,AC,DMST,REFURB
00847946013981Defibrillator ,MAIN,CCT,MANUAL-1,12 LEAD,SPO2,BIPHASIC,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
00847946013967Defibrillator ,MAIN, BASIC-4, 12LEAD,SPO2,BIPHASIC,AC,RC,PC,SM,CM,ENG,REFURB
00847946013950Defibrillator ,MAIN, EMTD-2,AED,12LEAD,SPO2,BIPHASIC,AC,EL,RC,SM,CDMK,DMST,REFURB
00847946013943Defibrillator ,MAIN, MANUAL-2,12LEAD,SPO2,BIPHASIC,AC,EL,RC,SM,CDM, ENG,REFURB
00847946013936Defibrillator ,MAIN, BSC-3,12LEAD,SPO2,BIPHASIC,AC,EL,RC,SM,CDM, DMST, REFURB
00847946013875Defibrillator ,MAIN,MNL-1, 12LEAD,ETCO2,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,REFURB
00847946013868Defibrillator ,MAIN,BASIC-4,12LEAD BIPHASIC,BLUETOOTH,PACE,EL,RCD,SMR,CDMK,DC,DMST,REFURB
00847946013851Defibrillator ,MAIN,MANUAL-1,12 LEAD,BIPHASIC,EL,PACE,RCD,SMR,CDMK,DC,DMST,REFURB
00847946013844Defibrillator ,MAIN,BASIC-4,12LEAD BIPHASIC,PACE,EL,RCD,SMR,CDMK,DC,DMST,REFURB
00847946013820Defibrillator ,MAIN,EMTD-1,12LEAD,BIPHASIC,BLUETOOTH,AC,PC,EL,RC,SM,CDMK, DMST, REFURB
00847946013813Defibrillator ,MAIN,AED 12LEAD/BIPHASIC/AC/PC/EL/RC/SM/CDMK,REFURB
00847946013806Defibrillator ,MAIN,MAN-1,12LEAD,BIPHASIC,ENG
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