N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576023608
• Version / Model: 2051
• Catalog Number: 2051
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-27
• Public Version: 2
• Public Version Date: 2021-06-17
• Public Version Status: Update
• Public Device Record Key: d78e08b0-db0c-4fc6-b2fa-db781def4b29
• Distribution End Date: 2021-06-16

Device Description

CLED / Mueller Hinton, 15x100, Biplate, 10/pk For the isolation, enumeration, and presumptive identification of urinary pathogens Section I: CLED (Cystine Lactose Electrolyte Deficient) Section II: Mueller Hinton

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: 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
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	866.1700	2
JSI	Culture Media, Selective And Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of 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	00816576023592	GS1
Primary	00816576023608	GS1

Customer Contacts

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

Storage Conditions

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