InTray® BHI

Basic Information

• Brand Name: InTray® BHI
• Primary DI: B08815030
• Version / Model: 1503
• Catalog Number: 21-503-001
• Company Name: BIO-MED DIAGNOSTICS, INC.
• Labeler DUNS: 605213545
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-12
• Public Version: 2
• Public Version Date: 2019-07-18
• Public Version Status: Update
• Public Device Record Key: 6982f3e0-0fe5-4451-beeb-9bc06d6f92aa

Device Description

Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.

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
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used 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
Package	B08815034	HIBCC	Box	20	In Commercial Distribution
Primary	B08815030	HIBCC
Package	B08815032	HIBCC	Box	5	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius