989803101571

GUDID 10884838001166

Philips Medical Systems

Electrocardiographic recording paper

• Primary Device ID: 10884838001166
• NIH Device Record Key: c05917dd-6a93-4ca6-8e9a-4bdfc1a7a882
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803101571
• Catalog Number: 989803101571
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

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Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838001169 [Unit of Use]
GS1	10884838001166 [Primary]

FDA Product Code

• DSF: RECORDER, PAPER CHART

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-07
• Device Publish Date: 2019-07-19

Devices Manufactured by Philips Medical Systems

• 10884838000671 - Paper: 2021-11-18
• 00884838107199 - PageWriter: 2021-10-15
• 20884838013517 - NA: 2021-10-01
• 20884838013524 - NA: 2021-10-01
• 20884838091782 - Microstream Advance Adult Oral-Nasal CO2 Filter Line: 2021-08-02
• 20884838091829 - Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line: 2021-08-02
• 20884838091836 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line: 2021-08-02
• 20884838091850 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line: 2021-08-02