Home GUDID 00841594100024 MALDI Biotyper CA System
Primary DI 00841594100024
Brand MALDI Biotyper CA System
Company Bruker Scientific LLC
Model 8603464
Catalog number 8603464
Device description Biotyper system for clinical use in the USA.
Published 2016-09-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name PEX System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841594100024 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841594100024 00841594100024 841594100024 0841594100024
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 79500 KiloPascal Handling Environment Humidity 20 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 61 Degrees Fahrenheit 91 Degrees Fahrenheit Special Storage Condition, Specify 0 0 6560 ft operating altitude Special Storage Condition, Specify 0 0 non-condensing at 91 degrees F Special Storage Condition, Specify 0 0 non-condensing, for reference only Storage Environment Humidity 15 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 877298661 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841594110054 US IVD 48 Spot Target 8604532 8604532 2016-09-16 00841594100031 MALDI Biotyper - smart CA 8604784 8604784 2016-09-16 00841594110030 MBT-CA System BD 8604736 8604736 2016-09-16 00841594110047 BD Bruker MBT smart CA System 8605214 8605214 2016-09-21 10841594110013 US IVD-HCCA Matrix, Portioned 10 Tubes 8604531 8604531 2016-09-16 10841594110099 US IVD-Bruker Bacterial Test Standard, 5 Tubes 8604530 8604530 2016-09-16
Other Devices Sharing Product Codes# 
bruker.com