N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398023153
• Version / Model: R18
• Catalog Number: R18
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-04
• Public Version: 1
• Public Version Date: 2020-06-12
• Public Version Status: New
• Public Device Record Key: 1090b632-93c7-4edd-937a-b4dbba4c4299

Device Description

Brucella Broth, 13x100mm tube, 1ml, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics Brucella Broth is recommended for use as a general purpose growth media for the isolation, cultivation, and differentiation of a variety of fastidious organisms, such as Streptococcus and Brucella spp. in clinical and food samples.

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
JSC	Culture Media, General Nutrient Broth	Microbiology	866.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to 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	00819398023146	GS1
Primary	00819398023153	GS1

Customer Contacts

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

Storage Conditions

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