AccessGUDID - DEVICE: VITEK® 2 AST-XN15 (03573026620295)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-XN15
Version or Model: VITEK® 2 AST-XN15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026620295
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

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 [?]
K032861	000
K040845	000
K121546	000
K152075	000
K161437	000
K161510	000
K163006	000
K163083	000
K172944	000
K183360	000
K183551	000
N50510	082
N50510	093
N50510	115
N50510	120
N50510	127

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: 8f672f92-9ece-4001-a134-d11832f94871
Public Version Date: May 10, 2022
Public Version Number: 2
DI Record Publish Date: June 22, 2020