ONLINE TDM Vancomycin Gen.3

Basic Information

• Brand Name: ONLINE TDM Vancomycin Gen.3
• Primary DI: 07613336121627
• Version / Model: 08058849190
• Catalog Number: 08058849190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-05
• Public Version: 2
• Public Version Date: 2020-11-27
• Public Version Status: Update
• Public Device Record Key: 99e18a7a-ab7f-4c1d-a8b8-21f885469636
• Distribution End Date: 2020-04-03

Device Characteristics

• Single Use: Yes
• 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: 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
LEH	RADIOIMMUNOASSAY, VANCOMYCIN	Clinical Toxicology	862.3950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61014	Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336121627	GS1

Premarket Submissions

Submission Number	Supplement Number
K152245	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius