AccessGUDID - DEVICE: VITEK® MS CHCA (03573026556662)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® MS CHCA
Version or Model: VITEK® MS CHCA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026556662
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: The VITEK MS-CHCA matrix is used with the VITEK® MS System to enable identification of microorganisms. The matrix absorbs energy from the VITEK MS laser and transfers it to the microorganisms

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?
61643	Microbial identification mass spectrometry system IVD	An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN130013	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: 219507fb-fd6c-4522-86f6-4ccc93686e69
Public Version Date: January 13, 2022
Public Version Number: 4
DI Record Publish Date: December 19, 2016