MBT Pilot System - US IVD 1875058

GUDID 04251204326304

Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA

Bruker Daltonik GmbH

Microbial identification mass spectrometry system IVD

• Primary Device ID: 04251204326304
• NIH Device Record Key: 847c3ab2-e6ae-455a-864f-57936382a85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MBT Pilot System - US IVD
• Version Model Number: 1875058
• Catalog Number: 1875058
• 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
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251204326304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193419

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: 2021-02-19
• Device Publish Date: 2021-02-11

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: 2021-02-19Visual support for manual sample preparation 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: 2020-12-17 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