N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576026685
• Version / Model: 6036
• Catalog Number: 6036
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 867d3ac0-97d3-4b82-b73e-0eb2d81aa10a

Device Description

Tryptic Soy Broth (TSB), 10ml, 16x125mm tube, optically clear, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.

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	00816576026678	GS1
Primary	00816576026685	GS1

Customer Contacts

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

Storage Conditions

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