N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398026239
• Version / Model: K73
• Catalog Number: K73
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-02
• Public Version: 1
• Public Version Date: 2020-06-10
• Public Version Status: New
• Public Device Record Key: b97ca110-4d03-4bd7-a08b-15181f9a12be

Device Description

Fluid Thioglycollate with Hemin and Vitamin K, 16x125mm tube, order by the package of 20 For the cultivation of aerobic, microaerophilic, and anaerobic microorganisms in normally sterile materials.

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	00819398023979	GS1
Primary	00819398026239	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius