MALDI Biotyper-BD sirius CA System 1890133

GUDID 04251204326175

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

Bruker Daltonik GmbH

Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD

• Primary Device ID: 04251204326175
• NIH Device Record Key: cf0806b8-49f1-4812-ac50-37ca7d96fdb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MALDI Biotyper-BD sirius CA System
• Version Model Number: 1890133
• Catalog Number: 1890133
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251204326175 [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

Devices Manufactured by Bruker Daltonik GmbH

• 04251204326182 - MBT Sepsityper Kit US IVD: 2021-02-19 Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA
• 04251204326298 - MBT Galaxy System - US IVD: 2021-02-19 Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA
• 04251204326304 - MBT Pilot System - US IVD: 2021-02-19 Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA
• 04251204326175 - MALDI Biotyper-BD sirius CA System: 2020-12-17Biotyper system for clinical use in the USA, with smartbeam laser.
• 04251204326175 - MALDI Biotyper-BD sirius CA System: 2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser.
• 04251204326311 - MALDI Biotyper sirius one CA System: 2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser.
• 04251204326359 - MALDI Biotyper-BD sirius one CA System: 2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser.
• 04251204326168 - MALDI Biotyper sirius CA System: 2019-07-09 Biotyper system for clinical use in the USA, with smartbeam laser.
• 04251204325659 - US IVD-HCCA Matrix, Portioned 10 Tubes: 2018-10-05 HCCA Matrix, 10 tubes