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
443624
In Commercial Distribution
443624
BECTON, DICKINSON AND COMPANY
BD Phoenix™ M50 Automated Microbiology System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LON | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 18 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Height: 21 Inch |
Width: 32 Inch |
Depth: 30 Inch |
Device Record Status
857096f8-92be-43f7-a562-b0da001bfd87
March 29, 2018
2
October 17, 2016
March 29, 2018
2
October 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com