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

GUDID

Device Identifier (DI) Information

Brand Name: BD Phoenix™ M50 Automated Microbiology System
Version or Model: 443624
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 443624
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904436247
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Phoenix™ M50 Automated Microbiology System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Height: 21 Inch
Width: 32 Inch
Depth: 30 Inch

Device Record Status

Public Device Record Key: 857096f8-92be-43f7-a562-b0da001bfd87
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 17, 2016