Leica Biosystems CytoVision CV TERMINAL SERVER USER LICENSE K/F

Basic Information

• Brand Name: Leica Biosystems CytoVision CV TERMINAL SERVER USER LICENSE K/F
• Primary DI: 00849832013266
• Version / Model: 23SWRRMTKFX016
• Company Name: Leica Biosystems Richmond, Inc.
• Labeler DUNS: 082930884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 412f068c-9b86-4a09-b014-651fad87e957

Device Description

CV TERMINAL SERVER USER LICENSE K/F

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
JOY	DEVICE, AUTOMATED CELL-LOCATING	Hematology	864.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36870	Network server	A device designed to provide electronic data services within a computerized network (e.g., file services like collecting and storing data). It may be a part of a patient monitoring, nurse call, or home alert system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849832013266	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K042542	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify