AccessGUDID - DEVICE: MBT-CA System BD (00841594110030)

GUDID

Device Identifier (DI) Information

Brand Name: MBT-CA System BD
Version or Model: 8604736
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8604736
Company Name: Bruker Scientific LLC

Primary DI Number: 00841594110030
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 877298661 *Terms of Use

Device Description: Biotyper system for clinical use in the USA, for Becton Dickinson.

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):	No
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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: non-condensing at 91F
Special Storage Condition, Specify: 6560 ft operating altitude
Special Storage Condition, Specify: non-condensing, for reference only
Handling Environment Atmospheric Pressure: less than 79500 KiloPascal
Handling Environment Temperature: between 61 and 91 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5bdf6d00-c207-4148-9ca9-611d9ae09b70
Public Version Date: September 26, 2022
Public Version Number: 6
DI Record Publish Date: September 16, 2016