AccessGUDID - DEVICE: VITEK® DENSICHEK® Display Base (03573026605667)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® DENSICHEK® Display Base
Version or Model: 422220
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026605667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36910	Photometer, absorbance/transmission, automated	An electrically-powered, automated, stand-alone laboratory instrument intended to be used to determine the absorbance or transmission of light energy transmitted through a substance, typically a solution/liquid (e.g., saliva, urine), or gas. It is used for diagnostic and/or research purposes and detects scattered light intensity, absorption and/or fluorescence.	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 [?]
K192110	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 -15 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd12a274-2050-46c6-aef6-b2b97d79fda0
Public Version Date: April 26, 2022
Public Version Number: 4
DI Record Publish Date: December 06, 2019