MALDI Biotyper CA System

Basic Information

• Brand Name: MALDI Biotyper CA System
• Primary DI: 00841594100024
• Version / Model: 8603464
• Catalog Number: 8603464
• Company Name: Bruker Scientific LLC
• Labeler DUNS: 877298661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-09-26
• Public Version Status: Update
• Public Device Record Key: d2efb568-2e50-4a7c-a5de-a7346ec17904
• Distribution End Date: 2019-05-31

Device Description

Biotyper system for clinical use in the USA.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEX	System, mass spectrometry, maldi tof, microorganism identification, cultured isolates	Microbiology	866.3361	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841594100024	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 6560 ft operating altitude
• Type: Special Storage Condition, Specify
• Special Conditions: non-condensing, for reference only
• Type: Special Storage Condition, Specify
• Special Conditions: non-condensing at 91 degrees F
• Type: Handling Environment Humidity
• Temperature Range: 20 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: High: 79500 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 61 – 91 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit