MBT-CA System BD 8604736

GUDID 00841594110030

Biotyper system for clinical use in the USA, for Becton Dickinson.

BRUKER DALTONICS INC.

Microbial identification mass spectrometry system IVD

• Primary Device ID: 00841594110030
• NIH Device Record Key: 5bdf6d00-c207-4148-9ca9-611d9ae09b70
• Commercial Distribution Discontinuation: 2019-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MBT-CA System BD
• Version Model Number: 8604736
• Catalog Number: 8604736
• Company DUNS: 877298661
• Company Name: BRUKER DALTONICS INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing at 91F
• Special Storage Condition, Specify: Between 0 and 0 *6560 ft operating altitude
• Special Storage Condition, Specify: Between 0 and 0 *non-condensing, for reference only
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841594110030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130831

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-25
• Device Publish Date: 2016-09-16

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