CHARGER

GUDID 00847946098926

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946098926
• NIH Device Record Key: 6a8f0460-09e2-45a7-8dbc-f7ce69de71eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHARGER
• Version Model Number: 1004-0302-01-66
• 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946098926 [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

On-Brand Devices [CHARGER]

• 00847946098957: 1211-000100-66
• 00847946098926: 1004-0302-01-66
• 00847946098919: 1004-0302-01
• 00847946022204: 1007-001050-01
• 00847946022181: 1211-000100-01
• 00847946022174: 1119-0500
• 00847946021993: 1004-0302-030
• 00847946019976: SUREPOWER CHARGING STATION, REFURB