M SERIES CCT

GUDID 00847946099312

Defibrillator ,MAIN,CCT,MAN-1,12 LD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHASIC,AC,AW

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946099312
• NIH Device Record Key: 05575fe3-cdb8-4cfe-abc7-0af74e2abf4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M SERIES CCT
• Version Model Number: 40021911100124010
• 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 Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946099312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011865

FDA Product Code

• DSK: COMPUTER, BLOOD-PRESSURE

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: 2014-09-25

On-Brand Devices [M SERIES CCT]

• 00847946099312: Defibrillator ,MAIN,CCT,MAN-1,12 LD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHASIC,AC,AW
• 00847946024512: MAIN,MNL-1,CCT,12LD,SPO2,NIBP,ETCO2,IBP,TEMP,BIPHSC,PC,RCD,SMR,AC,DMST,REFURB
• 00847946014773: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,MUSE,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMS
• 00847946014445: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST,REF
• 00847946014438: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,NELLCOR,RCD,SMR,CDMK,AC,
• 00847946014421: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST, RE
• 00847946014414: Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946014407: Defibrillator ,MAIN,MAN-1,CCT,12 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946014391: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,BIP,PACE,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946013530: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946013523: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946013509: Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,REFUR
• 00847946013493: Defibrillator ,MAIN CCT,MAN-2,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,RCD,SMR,CDMK,AC,DMST,REFURB
• 00847946007331: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,MUSE,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMS
• 00847946007324: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,MUSE,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMS
• 00847946006549: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946006532: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,DC,DMST
• 00847946006525: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST,NEL
• 00847946006518: Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,NELLCOR,AC,DMST
• 00847946006501: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946006495: Defibrillator ,MAIN,CCT,MAN-2,12 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIP,RCD,SMR,CDMK,AC,DMST
• 00847946006488: Defibrillator ,MAIN,MAN-1,CCT,12 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,NELLCOR,RCD,SMR,CDMK,AC,DMS
• 00847946006471: Defibrillator ,MAIN,MAN-1,CCT,12 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946006457: Defibrillator ,MAIN,CCT,MAN-1,12 LEAD,SPO2,ETCO2,NIBP,BIP,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946004910: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,NELL
• 00847946004903: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946004897: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,DC,DMST
• 00847946004873: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946004859: Defibrillator ,MAIN,CCT,MAN-1,3/5 LEAD,SPO2,ETCO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946004835: Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLC
• 00847946004828: Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST,NELLC
• 00847946004811: Defibrillator ,MAIN CCT,MAN-1,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,PACE,RCD,SMR,CDMK,AC,DMST
• 00847946004804: Defibrillator ,MAIN CCT,MAN-2,3/5 LEAD,SPO2,NIBP,IBP,TEMP,BIPHSC,RCD,SMR,CDMK,AC,DMST