AccessGUDID - DEVICE: VITEK® 2 AST-YS05 (03573026529758)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-YS05
Version or Model: VITEK® 2 AST-YS05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026529758
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents

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
NGZ	Susceptibility Test Plate, Antifungal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061945	000
K092454	000
K101566	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: 2aee0d89-b816-494c-bfa3-ded8a0d64058
Public Version Date: May 10, 2022
Public Version Number: 4
DI Record Publish Date: January 09, 2017