Fully Automated Urine Particle Analyzer UF-1000i

Basic Information

• Brand Name: Fully Automated Urine Particle Analyzer UF-1000i
• Primary DI: 04987562408542
• Version / Model: 05366719
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 6
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 7efdff80-5965-4edb-9e2a-a3a38f682487

Device Description

Sysmex UF-1000i™ Automated Urine Particle Analyzer

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
LKM	COUNTER, URINE PARTICLE	Hematology	864.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57839	Flow cytometry analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987562408542	GS1

Customer Contacts

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