ZOLL BATTERY

GUDID 00847946098971

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946098971
• NIH Device Record Key: 2b7eac2e-d97e-4866-a25f-9dbbeb6ceb5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL BATTERY
• Version Model Number: 1004-1070-01
• 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: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946098971 [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: 2016-06-08

Devices Manufactured by Zoll Medical Corporation

• 00847946049928 - SurePower 4: 2025-06-26 CHARGER ADAPTER, SUREPOWER 4
• 00812394022823 - ZENIX: 2025-06-25 CABLE, MFC, THOR, EC53
• 00812394026296 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM, CPR EXPANSION PACK, US, REFURB (T
• 00812394026302 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM, CPR EXPANSION PACK, US, REFURB (T
• 00812394026319 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU
• 00812394026326 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU
• 00812394026333 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU
• 00812394026364 - X SERIES: 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, BVM, NIBP, CPR EXPANSION PACK, CANADIAN, REFURB, (TIER 2)