Home GUDID B90900511 BacterioScan 216Dx System
Primary DI B90900511
Brand BacterioScan 216Dx System
Company BACTERIOSCAN, INC.
Model Clear Cartridge - 4 Well Tray
Device description Disposable used in system
Published 2020-10-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B9090051 Primary HIBCC 0 B90900511 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Microbial incubator/imaging system IVD An electrically-powered device intended to provide ideal conditions for microbial growth with an incubator, and to capture digital images of the specimens contained within the incubator at specified time intervals. It consists of an incubator unit with multiple shelves, a camera and a display unit for microbial growth monitoring. The system automatically monitors and controls temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It may have an integrated robotic transfer arm for loading and unloading the incubator onto/from other instruments. The device may be a single unit or modular assembly.
Regulatory Flags# DUNS number 029599160 Device count 4 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B9090051 BacterioScan 216Dx System Clear Cartridge - 4 Well Tray 2020-10-21 B9090052 BacterioScan 216Dx System Clear Cartridge - 4 Well Case 2020-10-21 B9090020 BacterioScan 216Dx System Appliance 216DxA4 2020-10-21 B9090050 BacterioScan 216Dx System Clear Cartridge - 4 Well 2020-10-21 B90900522 BacterioScan 216Dx System Clear Cartridge - 4 Well Case 2020-10-21 B9090010 BacterioScan 216Dx System 216Dx 2020-09-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B9090051 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-10-21 B9090052 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-10-21 B9090020 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-10-21 B9090050 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-10-21 B90900522 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-10-21 B9090010 BacterioScan 216Dx System BACTERIOSCAN, INC. QBQ 2020-09-15