M SERIES

GUDID 00847946004446

Defibrillator ,MAIN, EMTD-2,AED,3/5LEAD,SPO2/ETCO2,AC,EL,RC,SM,CDMK, ENG

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946004446
• NIH Device Record Key: 2f24a40e-532f-4aa7-8cec-51a449e53f01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M SERIES
• Version Model Number: 40010311000063010
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946004446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062537

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

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: 2014-09-08

On-Brand Devices [M SERIES]

• 00847946024499: MAIN, AED 3/5LEAD/SP02/AC/BIPH/EL/RC/SM/CM/ENG, REFURB
• 00847946014759: Defibrillator ,MAIN, EMTD-1,12LEAD,ETCO2,SPO2,BIPH,MUSE,AC,PACE,EL,RCD,SMR,CDMK,DMST,REFURB
• 00847946014247: Defibrillator ,MAIN,EMTD-1/AED,12LEAD,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946014230: Defibrillator ,MAIN,ACLS,MNL-1, 12LEAD,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946014223: Defibrillator ,MAIN,BASIC-4, 12LEAD,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946014193: Defibrillator ,MAIN,MANUAL-1,12 LEAD,SPO2,ETCO2,EL,PACE,RCD,SMR,CDMK,DC,DMST,REFURB
• 00847946014155: Defibrillator ,MAIN, EMTD-1,AED,12LEAD,ETCO2,SPO2,BIPH,AC,PACE,EL,RCD,SMR,CDMK, ENG,REFURB
• 00847946014087: Defibrillator ,MAIN, EMTD-1, 12LD/ETCO2/SPO2, AC,PACE,RCD,SMR,CDMK,ENG,REFURB
• 00847946014070: Defibrillator ,MNL-1/12LD/CO2/SP02/AC/PC/EL/RC/SM,REFURB
• 00847946014063: Defibrillator ,MAIN, BSC-4 12LD/ETCO2/SPO2/AC/PC/EL/RC/SM/CDM,REFURB
• 00847946014032: Defibrillator ,MAIN, EMTD-1,12 LEAD,SPO2,DC,PACE, RCD,SMR,CDMK,DMST, REFURB
• 00847946014025: Defibrillator ,MAIN,12-LD/SPO2/DC/PC/RC/SM/CM/ENG,REFURB
• 00847946014018: Defibrillator ,MAIN,EMTD-1,12LEAD,SPO2,BLUETOOTH,BIPH,AC,PC,RCD,SM,CDMK, DMST,REFURB
• 00847946013998: Defibrillator ,MAIN,EMTD-1/12LEAD/SPO2/BIPH/AC/PC/RCD,SM,CDMK, ENGLISH
• 00847946013974: Defibrillator ,MAIN, MNL 12LD/SPO2/AC/BIPH/PC/RC/SM/CDM, REFURB
• 00847946013929: Defibrillator ,MAIN,EMTD-1,12-LEAD,SP02,EL,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946013912: Defibrillator ,MAIN MNL1/SP02/12LD/AC/PC/EL/R/S/C/REFUR
• 00847946013905: Defibrillator ,MAIN, MANUAL-1,12LEAD,SPO2,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946013899: Defibrillator ,MAIN, EMTD-2, 12LEAD/SPO2/AC/EL/RC/SM/CDMK/ENGLISH,REFURB
• 00847946013882: Defibrillator ,MAIN,MNL2/12LD/SP02/AC/EL/RC/SM/CM/ENG,REFURB
• 00847946013837: Defibrillator ,MAIN,MNL-1 12-LEAD,DC/PC/EL/RC/SM/CM,REFURB
• 00847946013646: Defibrillator ,MAIN,EMTD-1,12LEAD,NIBP,ETCO2,SPO2,AC,PC,EL,RC,SM,CDMK,ENG,REFURB
• 00847946013639: Defibrillator ,MAIN,EMTD-1/AED,12LEAD,ETCO2,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946013622: Defibrillator ,MAIN,ACLS/MNL-1, 12LEAD,ETCO2,SP02,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946013608: Defibrillator ,MAIN,AED,12LEAD/AC/PC/EL/RC/SM/CDMK,REFURB
• 00847946013592: Defibrillator ,MAIN, MANUAL-1 12LEAD AC/PC/EL/RC/SM/CDM,REFURB
• 00847946013585: Defibrillator ,MAIN, BASIC-2, 12LEAD,AC,PC,EL,RC,SM,ENG,REFURB
• 00847946013578: Defibrillator ,MAIN BSC4/12-LEAD/AC/PC/RC/SM/CM/REFURB
• 00847946013561: Defibrillator ,MAIN, EMTD-2/AED,12LEAD,AC,EL,RC,SM,CM,ENG,REFURB
• 00847946013554: Defibrillator ,MAIN,MNL-2/12-LD/AC/EL/RC/SM/CM/ENG,REFURB
• 00847946013547: Defibrillator ,MAIN, BASIC-3, 12LEAD,AC,EL,RC,SM,CM,ENG,REFURB
• 00847946013516: Defibrillator ,MAIN,MAN-2,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946013400: Defibrillator ,MAIN,EMTD-5,BIPH/SPO2/AED/AC/EL/RC/SM/ENG,REFURB
• 00847946013363: Defibrillator ,MAIN,BASIC-3,BIPH/SP02/AC/EL/RC/SM/CM, REFURB
• 00847946013356: Defibrillator ,MAIN,SPO2/AC/PC/AED/EL/RC/SM/CDMK/REFURB
• 00847946013349: Defibrillator ,MAIN,MNL-1/SP02/AC/PC/EL/RC/SM/CM/REFURB
• 00847946013332: Defibrillator ,MAIN, HOSPITAL BASIC-2,SPO2, ENG, REFURB
• 00847946013325: Defibrillator ,MAIN, BSC-4,SPO2,AC,PC,EL,RC,SM,CDM, REFURB
• 00847946013318: Defibrillator ,MAIN, EMTD-2, 3/5LEAD,AUDIO,SPO2,AC,EL,RC,SM,CM,ENG, REFURB
• 00847946013301: Defibrillator ,MAIN ASSY,SP02,AC/AED/EL/RC/SM/CDMK/ENG,REFURB
• 00847946013295: Defibrillator ,MAIN ASSY,MNL-2,3/5LEAD,SP02,AC,EL,RC,SM,CDMK,ENG REFURB
• 00847946013288: Defibrillator ,MAIN ASSY,BASIC-6,3/5LEAD,SP02,AC,EL,RC,SM,CDM,ENG REFURB
• 00847946013271: Defibrillator ,MAIN, BSC-3 SPO2/AC/EL/RC/SM/CDMK, ENG, REFURB
• 00847946013233: Defibrillator ,MAIN ASSY MNL-1,DC/RCD/PC/EL/SMR/CDMKR,DMST,REFURB
• 00847946013141: Defibrillator ,MAIN,EMTD-1,ETCO2,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946013134: Defibrillator ,MAIN,ACLS,MNL-1,3/5LEAD,ETCO2,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG,REFURB
• 00847946013127: Defibrillator ,MAIN, BASIC-4, 3/5LEAD,ETCO2,SPO2,NIBP,AC,PC,EL,RC,SM,CM,ENG, REFURB
• 00847946013073: Defibrillator ,MAIN,EMTD-5,BIPH/AED/AC/EL/RC/SM/ENG, REFURB
• 00847946013004: Defibrillator ,MAIN, AC,PC,AED,EL,RC,SM,CDMK, REFURB
• 00847946012991: Defibrillator ,MAIN ASSY,ACLS,3/5LEAD,AC,PC,EL,RCD,SMR,CDMK,ENG REFURB