MALDI Biotyper sirius one CA System 1890232

GUDID 04251204326311

Biotyper system for clinical use in the USA, with smartbeam laser.

Bruker Daltonik GmbH

Microbial identification mass spectrometry system IVD

• Primary Device ID: 04251204326311
• NIH Device Record Key: 00fcb859-419d-41d2-8276-7a857f7a7a35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MALDI Biotyper sirius one CA System
• Version Model Number: 1890232
• Catalog Number: 1890232
• Company DUNS: 318387958
• Company Name: Bruker Daltonik GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *operating altitude
• Storage Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251204326311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163536

FDA Product Code

• PEX: System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

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: 2020-12-17
• Device Publish Date: 2020-12-09

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