AccessGUDID - DEVICE: VITEK® MS-DS (03573026554224)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 03573026554224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.

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?
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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08350dd3-ab07-4735-b979-a86f5d3b17ee
Public Version Date: April 30, 2024
Public Version Number: 4
DI Record Publish Date: December 23, 2016