N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576025459
• Version / Model: G225
• Catalog Number: G225
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 1
• Public Version Date: 2020-06-05
• Public Version Status: New
• Public Device Record Key: 5d8ed9e4-1461-4cc4-bbdb-82c71057a99b

Device Description

Non-Nutrient Agar, 15x100mm Plate, 20ml. Hardy Diagnostics Free-Living Amebae Media (Non-Nutrient Agar and Page's Saline) are recommended for the detection of free-living pathogenic Acanthamoeba and Naegleria spp. cysts, trophozoites, and flagellates in clinical, epidemiological, or public health specimens; also for products associated with contact lenses. Detection is accomplished by observing feeding tracks on agar media containing a film of E. coli.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576025442	GS1
Primary	00816576025459	GS1

Customer Contacts

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

Storage Conditions

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