E SERIES

GUDID 00847946099343

Defibrillator ,MAIN, AED-3, 12 LEAD, SPO2/ETCO2, GPS, PACE, AC, NO RAILS, DMST, REFURB

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946099343
• NIH Device Record Key: 07f5aa3c-566d-465b-872e-b77e7ae35364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E SERIES
• Version Model Number: 80001310010164013
• 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 Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946099343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111594

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: 2014-10-06

On-Brand Devices [E SERIES]

• 00847946099688: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, RAILS, DMST
• 00847946099503: Defibrillator ,MAIN, AED-1, 3/5 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, PACE, AC, RAILS, DMST
• 00847946099466: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, SPCO, BT/GPS, PACE, AC, LI-ION, NO RAILS,
• 00847946099411: Defibrillator ,MAIN, AED-2, 12 LEAD, SPO2/ETCO2/NIBP, GPS/BT, AC, NO RAILS, DMST
• 00847946099343: Defibrillator ,MAIN, AED-3, 12 LEAD, SPO2/ETCO2, GPS, PACE, AC, NO RAILS, DMST, REFURB
• 00847946099336: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS, DMST
• 00847946024604: MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST, REFURB
• 00847946024598: MAIN, AED-2, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS/BT, LI-ION, AC, NO RAILS, DMST, REFURB
• 00847946024581: MAIN, AED-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, VOICE, NO RAILS, DMST, REF
• 00847946024574: MAIN, AED-2, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS/BT, LI-ION, AC, NO RAILS, DMST, REFURB
• 00847946024567: MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, PACE, DC, NO RAILS, DMST, REFURB
• 00847946024550: MAIN, AED-2, 12 LEAD, SPO2/ETCO2/NIBP, GPS/BT, LI-ION, AC, NO RAILS, DMST, REFURB
• 00847946024543: MAIN, AED-2, 3/5 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, AC, NO RAILS, DMST, REFURB
• 00847946024536: MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, RAILS, VOICE, DMST, REFURB
• 00847946024529: MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, RAILS W/ PAD. WELL, DMST, REFURB
• 00847946019587: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS w/GPS, PACE, DC, LI-ION, NO RAILS,
• 00847946019570: Defibrillator ,MAIN, ACLS-2, 12 LEAD, SPO2/ETCO2/NIBP, GPS/BT, AC, w/RAILS, DMST, REFURB
• 00847946019563: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, ENHANCED BT/GPS, PACE, DC, LI-ION, N
• 00847946019556: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, AED, AC, LI-ION, NO RAILS, D
• 00847946019549: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS w/GPS, PACE, DC, LI-ION, NO RAILS,
• 00847946019495: Defibrillator ,MAIN, ACLS-3, 12 LEAD, SPO2/ETCO2, GPS, AED, AC, w/SOFTCASE, DMST
• 00847946018290: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2, BT/GPS, PACE, AC, NO RAILS, DMST, REFURB
• 00847946018283: Defibrillator ,MAIN, ACLS-3, 12 LEAD, SPO2/ETCO2, GPS/BT, PACE, AC, NO RAILS, DMST, REFURB
• 00847946017842: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMS
• 00847946017835: Defibrillator ,MAIN, AED-2, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS/BT, AC, NO RAILS, DMST
• 00847946017828: Defibrillator ,MAIN, AED-2, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS/BT, AC, NO RAILS, DMST
• 00847946017811: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, DC, LI-ION, NO RAILS, DMST
• 00847946017804: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, GPS, PACE, AC, LI-ION, NO RAILS, DMST
• 00847946017798: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, GPS, PACE, DC, NO RAILS, DMST
• 00847946017781: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, GPS, PACE, AC, NO RAILS, DMST
• 00847946017774: Defibrillator ,MAIN, AED-2, 12 LEAD, SPO2/ETCO2/NIBP, GPS, AC, NO RAILS, DMST
• 00847946017767: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, LI-ION, AC, RAILS, DMST
• 00847946017750: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/ETCO2/NIBP, GPS, PACE, DC, NO RAILS, DMST
• 00847946017743: Defibrillator ,MAIN, AED-3, 12 LEAD, SPO2/ETCO2, BT/GPS, PACE, AC, RAILS, DMST
• 00847946016111: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO R
• 00847946016104: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RA
• 00847946016098: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO R
• 00847946016081: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO R
• 00847946016074: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, GPS/BT, PACE, AC, NO RAILS, DM
• 00847946016067: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, GPS, PACE, AC, NO RAILS, DMST,
• 00847946016050: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/SPMET/ETCO2/NIBP, GPS, PACE, AC, RAILS, DMST, REF
• 00847946016043: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS, D
• 00847946016036: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS,
• 00847946016029: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, NO RAILS,
• 00847946016012: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, PACE, AC, LI-ION, NO RAILS, DMS
• 00847946016005: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST, REF
• 00847946015992: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST, RE
• 00847946015985: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST, RE
• 00847946015978: Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, GPS, PACE, AC, NO RAILS, DMST, REFUR
• 00847946015961: Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, GPS/BT, PACE, LI-ION, AC, NO RAILS, DMST,