AccessGUDID - DEVICE: VITEK® 2 AST-GP68 (03573026530792)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-GP68
Version or Model: VITEK® 2 AST-GP68
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026530792
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 Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae

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 [?]
K020871	000
K031410	000
K031865	000
K051849	000
K053186	000
K063597	000
K063623	000
K083383	000
N50510	131
N50510	132
N50510	133
N50510	135
N50510	136
N50510	137
N50510	138
N50510	139
N50510	145

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: 7e1db16f-a010-4696-96b0-6bf7dfcee545
Public Version Date: May 11, 2022
Public Version Number: 4
DI Record Publish Date: January 09, 2017