AccessGUDID - DEVICE: BD Phoenix™ EMERGE™ AST Indicator Solution (30382902460153)

GUDID

Device Identifier (DI) Information

Brand Name: BD Phoenix™ EMERGE™ AST Indicator Solution
Version or Model: 246015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 246015
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902460153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Phoenix™ Emerge™ AST Indicator Solution

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:	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43534	Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) against a specific bacterial microorganism, isolated from a clinical specimen by culture.	Active	false

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 [?]
K020321	000

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

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 6 Milliliter

Device Record Status

Public Device Record Key: 495b72c0-27c9-4198-b645-72d095fdafcd
Public Version Date: July 09, 2024
Public Version Number: 2
DI Record Publish Date: February 15, 2021