FilterLine/Microstream 989803105561

GUDID 20884838071388

Philips Medical Systems

Gas-sampling/monitoring respiratory tubing, single-use, non-sterile Gas-sampling/monitoring respiratory tubing, single-use, non-sterile Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 20884838071388
• NIH Device Record Key: 0531638a-bb60-4d1b-bb7e-77b1e6f3c812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilterLine/Microstream
• Version Model Number: 989803105561
• Catalog Number: 989803105561
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
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Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838071384 [Unit of Use]
GS1	20884838071388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113441

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2016-12-20

On-Brand Devices [FilterLine/Microstream]

• 20884838071388: 989803105561
• 20884838071371: 989803105541
• 20884838071364: 989803105531
• 20884838071357: 989803160261
• 20884838071340: 989803160251
• 20884838071333: 989803160241