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

• 00847946096168 - AED PLUS: 2024-04-05 AED PLUS, PS SERIES, W/AED CVR, LCD, NO VOICE RECORDING, ENGLISH, REFURB
• 00847946096199 - AED PLUS: 2024-04-05 AED PLUS, PS SERIES NO GRAPHICS, W/AED CVR, LCD, NO VOICE RCDG, ENG, REFURB
• 00847946096212 - AED PLUS: 2024-04-05 AED PLUS, PS SERIES W/BASIC CVR, LCD, VOICE RCDG, ENG, REFURB
• 00847946096229 - AED PLUS: 2024-04-05 AED PLUS, PS SERIES W/AED CVR, LCD, VOICE RCDG, ENG, REFURB
• 00847946096243 - AED PLUS: 2024-04-05 AED PLUS, PS SERIES NO GRAPHICS, W/AED CVR, LCD, VOICE RCDG, ENG
• 00847946096298 - AED PRO: 2024-04-05 AED PRO, SEMI AUTOMATIC ONLY, NO BATTERY, NO ELECTRODES, REFURB
• 00847946096472 - AED PRO: 2024-04-05 AED PRO, SEMI AUTO W/MNL OVERRIDE, NO VOICE, LCD, ENGLISH, REFURB
• 00847946096533 - AED PLUS: 2024-04-05 AED PLUS, PA SERIES, NO LCD, NO VOICE RCDG, ENG, REFURB