IMMY

Basic Information

• Brand Name: IMMY
• Primary DI: 00816387020469
• Version / Model: ID1019
• Company Name: Immuno-Mycologics, Inc.
• Labeler DUNS: 099550915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-11
• Public Version: 1
• Public Version Date: 2023-12-19
• Public Version Status: New
• Public Device Record Key: 6f12e915-35f4-40c4-b934-fb7778d794e9

Device Description

4-Series Cleargel ID Plates, Small Well

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JZP	Plates, Ouchterlony Agar	Immunology	866.4600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64947	Agar medium preparation kit IVD	A collection of devices intended to be used for the preparation of an agar medium for subsequent culture of a clinical specimen or other diagnostic testing (e.g., minimum susceptibility testing). It typically includes agarose, a specific culture media formulation and transfer devices (e.g., vial adaptor, syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816387020469	GS1

Customer Contacts

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