ResQPOD ITD 10, Military

GUDID 00847946028329

RESQPOD ITD 10, MILITARY

Zoll Medical Corporation

Demand valve

• Primary Device ID: 00847946028329
• NIH Device Record Key: 974b61f1-15ec-4a62-a93f-c2a524814046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResQPOD ITD 10, Military
• Version Model Number: 12-0242-030
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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 Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946028329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033401

FDA Product Code

• BWF: SPIROMETER, THERAPEUTIC (INCENTIVE)
• PIZ: Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

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: 2020-07-02
• Device Publish Date: 2020-06-24

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