Dunlee

GUDID 00884838117761

1.5 T/R Quad Extremity Coil

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838117761
• NIH Device Record Key: 773f3fc1-a93f-4d04-b5df-3e4e7f4e9860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dunlee
• Version Model Number: 459801412012
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838117761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222257

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2024-02-02
• Device Publish Date: 2024-01-25

On-Brand Devices [Dunlee]

• 00884838117761: 1.5 T/R Quad Extremity Coil
• 00884838117785: 1.5T 8CH T/R Knee Coil