HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00816576028870
• Version / Model: Z7501
• Catalog Number: Z7501
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 1
• Public Version Date: 2020-08-19
• Public Version Status: New
• Public Device Record Key: 887b542c-2a5b-46f4-81ac-bc9b231c9aec

Device Description

Vancomycin, 5mcg, Va-5, for the differentiation of anaerobic bacteria based on susceptibility to vancomycin, 1 x 50 disks, for the identification of anaerobes For the differentiation of anaerobic bacteria based on susceptibility to vancomycin.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61992	Vancomycin/colistin selective isolation disc IVD	A disc impregnated with a defined amount of the antimicrobials vancomycin and colistin, intended to be used for the selective isolation of microorganisms that are not susceptible to the antimicrobials (e.g., Neisseria meningitidis) from a clinical specimen in a culture medium, using a disc diffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576028863	GS1
Primary	00816576028870	GS1

Customer Contacts

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

Storage Conditions

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