AccessGUDID - DEVICE: VITEK® 2 AST-GP67 (03573026530648)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® 2 AST-GP67
Version or Model: VITEK® 2 AST-GP67
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026530648
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 the susceptibility of Staphylococcus spp., Enterococcus spp., and 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 [?]
K032399	000
K032738	000
K032766	000
K050976	000
K053097	000
K072668	000
K072695	000
K080201	000
N50510	084
N50510	085
N50510	102
N50510	106
N50510	108
N50510	111
N50510	113
N50510	116
N50510	117

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: 13c9f42c-79f0-4dce-9555-7232d0436c53
Public Version Date: May 11, 2022
Public Version Number: 4
DI Record Publish Date: January 09, 2017