Applicator - Simplex C76

Basic Information

• Brand Name: Applicator - Simplex C76
• Primary DI: 03573026250768
• Version / Model: 559802
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 2
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: 635405da-aed7-4957-8248-a5014eb9f668

Device Description

The Simplex instrument automates placement of up to 6 different Etest strips from foam packaging directly onto agar plates.

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: 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
JWY	Manual antimicrobial susceptibility test systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62035	Antimicrobial susceptibility strip dispenser IVD	A mains electricity (AC-powered) device intended to be used to position and apply test strips impregnated with antimicrobial agents onto agar plates, or other culture media, for the determination of the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026250768	GS1

Premarket Submissions

Submission Number	Supplement Number
K102668	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius