BD Bruker MBT smart CA System 8605214

GUDID 00841594110047

Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.

BRUKER DALTONICS INC.

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: 00841594110047
• NIH Device Record Key: a5c6da03-b9c9-49d1-af7f-3da48417150b
• Commercial Distribution Discontinuation: 2019-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BD Bruker MBT smart CA System
• Version Model Number: 8605214
• Catalog Number: 8605214
• 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

• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 and 79500 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841594110047 [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: 2016-09-21

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