989803106071

GUDID 20884838008650

Philips Medical Systems

General-purpose patient temperature probe, single-use

• Primary Device ID: 20884838008650
• NIH Device Record Key: 67ac454c-1b36-4e79-a1ff-96e0a1988e55
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803106071
• Catalog Number: 989803106071
• 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: false
• Expiration Date: true
• 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 -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -31 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838008656 [Unit of Use]
GS1	20884838008650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921561

FDA Product Code

• EZL: CATHETER, RETENTION TYPE, BALLOON

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-01

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