Fluoro Care Anti-Fade Mountant

Basic Information

• Brand Name: Fluoro Care Anti-Fade Mountant
• Primary DI: 00847627002471
• Version / Model: FP001G5
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: ba7113ba-0fa9-4fbd-b833-bb78e0f376d8

Device Characteristics

• Single Use: No
• 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
LEB	Mounting Media	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43550	Microscopy mounting medium IVD	A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip to preserve the specimen and enhance image quality during microscopic examination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627002471	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -20 Degrees Celsius