X SERIES ADVANCED

GUDID 00847946049959

DEVICE IDENTIFIER, MAIN ASSY, X SERIES ADVANCED MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, BVM, IBP, NIBP, SPO2, SPCO, SPMET (RAINBOW/MASIMO), CPR EXPANSION PACK, MOBILE STREAMING, GERMAN

Zoll Medical Corporation

Physiologic-monitoring defibrillation system

• Primary Device ID: 00847946049959
• NIH Device Record Key: 6992f83c-1efb-4fbb-8deb-abfaf0ce5239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X SERIES ADVANCED
• Version Model Number: 630-2241712-08
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946049959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112432

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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: 2022-06-03
• Device Publish Date: 2022-05-26

Devices Manufactured by Zoll Medical Corporation

• 00847946034092 - ZENIX: 2024-12-25 ASSEMBLY, GREEN CONNECTOR, ZENIX
• 00847946056094 - ZENIX: 2024-12-20 CABLE, LIMB LEAD ECG, IEC
• 00847946033965 - ZENIX: 2024-11-21 CABLE, ECG 3 LEAD SET, IEC
• 00847946027018 - CPR ELECTRODE, GEMINI: 2024-11-11 ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, SINGLE
• 00847946094706 - VENT: 2024-07-26 ZVENT, FULL FEATURED, HOSPITAL SW w/CARRY CAGE, RENTAL PROGRAM
• 00847946023522 - VENT: 2024-07-16 VENTILATOR,EAGLE II,731 SERIES, REFURB
• 00847946023539 - VENT: 2024-07-16 VENTILATOR,EAGLE II,731 SERIES,MRI, REFURB
• 00847946023546 - VENT: 2024-07-16 VENTILATOR,EMV+,731 SERIES, REFURB