N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576027477
• Version / Model: W23
• Catalog Number: W23
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-05
• Public Version: 1
• Public Version Date: 2020-06-15
• Public Version Status: New
• Public Device Record Key: e4c92cb5-2a64-40aa-91f8-9c4c5a389282

Device Description

Brucella Blood Agar with Hemin, and Vitamin K, 15x100mm plate, 26ml fill, order by the package of 10 (Brucella Agar with Hemin & Vitamin K) For the cultivation of anaerobes. A non-inhibitory general growth medium for all gram positive and gram negative anaerobic bacteria. Optimized formula for enhanced growth characteristics of anaerobes.

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
KZI	Culture Media, Enriched	Microbiology	866.2330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576027460	GS1
Primary	00816576027477	GS1

Customer Contacts

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

Storage Conditions

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