BlueMount™

Basic Information

• Brand Name: BlueMount™
• Primary DI: 00819398027182
• Version / Model: Z137
• Catalog Number: Z137
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-11
• Public Version: 1
• Public Version Date: 2020-06-19
• Public Version Status: New
• Public Device Record Key: 102441c9-c3c1-4313-a6f6-937fb731c1bd

Device Description

BlueMount™, permanent fungal stain, lactophenol cotton blue with PVA, 15ml each A permanent slide mounting media for mycology specimens that contains the stain lactophenol cotton blue. Produces a long lasting permanently stained slide. Contains polyvinyl alcohol (PVA) that will dry and set up hard to create a perfectly preserved slide.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027182	GS1

Customer Contacts

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

Storage Conditions

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