NA

Basic Information

• Brand Name: NA
• Primary DI: 04582275250404
• Version / Model: CD-15
• Company Name: KONAN MEDICAL, INC.
• Labeler DUNS: 690768619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: d9c54fdb-edac-4cae-8adc-8383b6ed1376

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• 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
NQE	Microscope, specular	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15132	Cell morphology analyser IVD, manual	An electrically-powered manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582275250404	GS1

Premarket Submissions

Submission Number	Supplement Number
K040373	000