VITEK® 2 0,45% Sodium Chloride Diluent

Basic Information

• Brand Name: VITEK® 2 0,45% Sodium Chloride Diluent
• Primary DI: 03573026556969
• Version / Model: VITEK® 2 0,45% Sodium Chloride Diluent
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 4
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: b7ed2a94-42b0-4896-bd8b-cf5f06caa97f

Device Description

VITEK 2.0 0.45% SALINE INDIVIDUAL BAG

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LON	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	Microbiology	866.1645	2
LTW	Susceptibility test cards, antimicrobial	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58673	Saline suspension medium/diluent IVD	A saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026463533	GS1		14	In Commercial Distribution
Primary	03573026556969	GS1

Premarket Submissions

Submission Number	Supplement Number
N50510	082

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius