SurePower 4

GUDID 00847946049928

CHARGER ADAPTER, SUREPOWER 4

Zoll Medical Corporation

Electrocardiographic electrode connector

Primary Device ID	00847946049928
NIH Device Record Key	9352863e-0e3e-4966-b2b2-212abd185c3c
Commercial Distribution Status	In Commercial Distribution
Brand Name	SurePower 4
Version Model Number	1016-001000-01
Company DUNS	055363428
Company Name	Zoll Medical Corporation
Device Count	1
DM Exempt	true
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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Storage Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946049928 [Primary]

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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2025-06-26
Device Publish Date	2025-06-18

Devices Manufactured by Zoll Medical Corporation

00847946049928 - SurePower 4	2025-06-26CHARGER ADAPTER, SUREPOWER 4
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)