AccessGUDID - DEVICE: VITEK® 2 AST-YS09 (03573026619350)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-YS09
Version or Model: VITEK® 2 AST-YS09
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026619350
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 ® Yeast Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant yeast.

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 [?]
K092454	000
K133817	000
K133952	000
K151817	000
K151923	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: c3cadde2-7540-48db-b672-862f0097f1c2
Public Version Date: May 10, 2022
Public Version Number: 2
DI Record Publish Date: April 05, 2019