Ventilator

GUDID 00847946024130

CLAMP WITH DOVETAIL,CCLAW

Zoll Medical Corporation

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• Primary Device ID: 00847946024130
• NIH Device Record Key: 75df3a08-6cd6-4277-97b8-799af3035696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventilator
• Version Model Number: 703-0904-16
• 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: 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
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946024130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162832

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-25

On-Brand Devices [Ventilator]

• 00847946024130: CLAMP WITH DOVETAIL,CCLAW
• 00847946023836: ASSEMBLY, 3-LITER RESERVOIR KIT
• 00847946023829: ACCESSORY KIT, AEV1
• 00847946045463: Ventilator
• 00847946050566: MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPP
• 00847946050399: MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPP
• 00847946050382: MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPP
• 00847946050375: MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPP
• 00847946050368: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL STANDARD, ZVENT, 4TH EDITION, HOSPITAL
• 00847946050351: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL STANDARD, ZVENT, 4TH EDITION, MRI
• 00847946050344: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL STANDARD, ZVENT 4TH EDITION
• 00847946050337: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASIC
• 00847946092863: KIT, ACCESSORIES, EMV+, MILITARY,W/ MASIMO, BERRY COMPLIANT