IMMY

Basic Information

• Brand Name: IMMY
• Primary DI: 00816387021145
• Version / Model: TBRB30
• Company Name: Immuno-Mycologics, Inc.
• Labeler DUNS: 099550915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 987b8b81-63b4-4814-aa5a-b0d367a1e5fe

Device Description

MycoDDR Resuspension Buffer C

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: 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42624	Sputum liquefaction/decontamination reagent IVD	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory disease (e.g., Streptococcus pneumoniae, Mycobacterium tuberculosis) in preparation for further processing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816387021145	GS1
Package	00816387021138	GS1		60	In Commercial Distribution

Customer Contacts

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