MBT Biotarget 96 US IVD

Basic Information

• Brand Name: MBT Biotarget 96 US IVD
• Primary DI: 04251204325772
• Version / Model: 1840380
• Catalog Number: 1840380
• Company Name: Bruker Daltonik GmbH
• Labeler DUNS: 318387958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-01-31
• Public Version: 4
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 9e6d7d01-ad65-45b7-9938-db6596cad0f8

Device Description

Disposable Ceramic Target

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
61954	Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the preparation or processing of a clinical specimen for subsequent liquid chromatography and/or mass spectrometry (LC/MS) separation and/or analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251204325772	GS1
Unit of Use	04251204325857	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163536	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Min shelf life 2 years.