N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576023929
• Version / Model: A16BX
• Catalog Number: A16BX
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-05-27
• Public Version: 1
• Public Version Date: 2020-06-04
• Public Version Status: New
• Public Device Record Key: b58351d6-0feb-4e1b-abc8-7eed96fabc3b

Device Description

Columbia Blood Agar, 15x100 monoplate, 10 pks of 10 IColumbia Agar Base with 5% Sheep Blood). For the cultivation of microorganisms.

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
58687	Enriched broth culture medium IVD	A broth 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 in a general-purpose broth medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576023905	GS1
Primary	00816576023929	GS1

Customer Contacts

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

Storage Conditions

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