B Cassette

Basic Information

• Brand Name: B Cassette
• Primary DI: 00894472000237
• Version / Model: 1
• Catalog Number: BP7562
• 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: ec111924-7a70-4865-b68c-48e13b29277c

Device Description

B Cassette Carton

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKR	System, Hemoglobin, Automated	Hematology	864.5620	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	00894472000237	GS1

Premarket Submissions

Submission Number	Supplement Number
K974784	000