ADVIA Centaur® Gentamicin MCM

Basic Information

• Brand Name: ADVIA Centaur® Gentamicin MCM
• Primary DI: 00630414527307
• Version / Model: 10322163
• Catalog Number: 5227559
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2024-11-04
• Public Version Status: Update
• Public Device Record Key: 04294a69-ceb0-4d0a-98ac-4fa7ff8aaf9d
• Distribution End Date: 2016-12-18

Device Description

Gentamicin Master Curve Material Set - CENTAUR - CONS

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCD	ENZYME IMMUNOASSAY, GENTAMICIN	Clinical Toxicology	862.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55276	Gentamicin therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414527307	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K953020	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store upright
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius