Model, AEV, Ventilator, IDF

GUDID 00847946020668

Ventilator

Zoll Medical Corporation

Transport electric ventilator

• Primary Device ID: 00847946020668
• NIH Device Record Key: 52c4bf45-dcb2-47dd-8180-52d909a1b3ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model, AEV, Ventilator, IDF
• Version Model Number: 799-AEV1-03
• 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

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	00847946020668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111473

FDA Product Code

• DQA: Oximeter

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: 2015-10-28

Devices Manufactured by Zoll Medical Corporation

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• 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)