Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693091060
• Version / Model: Acetone
• Catalog Number: 9011
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-28
• Public Version: 1
• Public Version Date: 2024-08-05
• Public Version Status: New
• Public Device Record Key: 46055d06-0c51-4e6a-8264-0b7400f74471

Device Description

Acetone is specifically designed for laboratory procedures. The product is a clear, colorless reagent that is highly quality controlled. Acetone is a known toxin. Ingestion may result in blindness or death. Precaution should be taken when handling Acetone. Protective gloves should be worn and work should be performed in a ventilated area. Acetone is a highly flammable product and must be stored in a flammable fire cabinet.

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: Yes
• 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
55471	Acetone IVD, reagent	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 qualitative and/or quantitative detection of acetone in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693091060	GS1