DEVICE: BD Phoenix™ M50 Automated Microbiology System (00382904436247)

Device Identifier (DI) Information

BD Phoenix™ M50 Automated Microbiology System
443624
In Commercial Distribution
443624
BECTON, DICKINSON AND COMPANY
00382904436247
GS1

1
122561087 *Terms of Use
BD Phoenix™ M50 Automated Microbiology System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Microorganism identification/antimicrobial-susceptibility analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of the antimicrobial susceptibility profile, using morphology, substrate utilization and/or biochemical reactivity, and by monitoring growth rates against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography and/or carbon dioxide production. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
LON SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 18 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 21 Inch
Width: 32 Inch
Depth: 30 Inch
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Device Record Status

857096f8-92be-43f7-a562-b0da001bfd87
March 29, 2018
2
October 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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+1(800)638-8663
Technical_services@bd.com
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