AccessGUDID - DEVICE: VITEK® 2 AST-ST02 (03573026554613)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-ST02
Version or Model: VITEK® 2 AST-ST02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026554613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus

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?
58605	General-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.	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 [?]
K110106	000
K111599	000
K111893	000
K111909	000
K111976	000
K112000	000
K112075	000
K112129	000
K112228	000
K121100	000
K121863	000
K122359	000
K131779	000
K132573	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
No Device Sizes

Device Record Status

Public Device Record Key: f6ab7233-263e-4da2-bff9-6fe189527a0e
Public Version Date: May 11, 2022
Public Version Number: 4
DI Record Publish Date: January 09, 2017