HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00816576027071
• Version / Model: Z9485
• Catalog Number: Z9485
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2025-07-14
• Public Version: 1
• Public Version Date: 2025-07-22
• Public Version Status: New
• Public Device Record Key: a783a84e-1105-4975-8fac-21b784de084c

Device Description

HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),5 x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam

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
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35733	Antimicrobial sensitivity disc dispenser IVD	A manually-operated IVD intended to be used for the storage and/or dispensing of antimicrobial sensitivity discs impregnated with antimicrobial agents onto agar or other culture media, for the antimicrobial susceptibility testing of culture isolates from clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576026975	GS1
Primary	00816576027071	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250454	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius