989803192151

GUDID 20884838075751

Philips Medical Systems

Electrocardiographic lead set, reusable

• Primary Device ID: 20884838075751
• NIH Device Record Key: 23b33342-3042-42f2-90a6-a79c23987162
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803192151
• Catalog Number: 989803192151
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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: 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

Customer Support Contacts

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Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
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• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
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• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 10 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838075757 [Unit of Use]
GS1	20884838075751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110287

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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: 2017-08-15

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