OPTI CCA E Cassette

Basic Information

• Brand Name: OPTI CCA E Cassette
• Primary DI: 00894472000244
• Version / Model: 1
• Catalog Number: BP7587
• Company Name: OPTI MEDICAL SYSTEMS, INC.
• Labeler DUNS: 801458279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-07
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: c4e53992-5b25-4782-b4ed-2d4d861804de

Device Description

OPTI CCA E Cassette

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52904	Multiple clinical chemistry enzyme IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894472000244	GS1

Premarket Submissions

Submission Number	Supplement Number
K974784	000