M SERIES BIPHASIC

GUDID 00847946019648

Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, NIBP, CF/STD, DMST

Zoll Medical Corporation

Physiologic-monitoring defibrillation system

• Primary Device ID: 00847946019648
• NIH Device Record Key: e7d281b0-9d3b-4661-a6b2-0b625ebb48f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M SERIES BIPHASIC
• Version Model Number: 30001006201330012
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946019648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990762

FDA Product Code

• DRO: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-21

On-Brand Devices [M SERIES BIPHASIC]

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