GEMINI

GUDID 10847946027015

ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, 8/CASE

Zoll Medical Corporation

Multifunction cardiac electrode, paediatric

• Primary Device ID: 10847946027015
• NIH Device Record Key: 1be74692-62bf-4496-ae31-bfe54df7c4ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMINI
• Version Model Number: 8900-000381-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10847946027015 [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: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by Zoll Medical Corporation

• 00812394026241 - X SERIES: 2025-05-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONT
• 00812394026258 - X SERIES: 2025-05-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4
• 00812394026265 - X SERIES: 2025-05-15 DEVICE IDENTIFIER, X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, D
• 00812394026647 - AED3: 2025-05-06 SEMI-AUTOMATIC, ZOLL AED 3, BRAZILIAN PORTUGUESE AHA, REFURB
• 00812394026654 - AED3: 2025-05-06 MAIN ASSEMBLY, SEMI-AUTOMATIC, ZOLL AED 3, SPANISH AHA, REFURB
• 00812394026661 - AED3: 2025-05-06 SEMI-AUTOMATIC, ZOLL AED 3, BRAZILIAN PORTUGUESE AHA, REFURB
• 00812394026845 - X SERIES: 2025-05-01 MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, SO. AMERICAN SP
• 00812394026852 - X SERIES: 2025-05-01 X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, SO. AMERICAN SPANISH