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 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 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

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