Fully Automated Urine Particle Digital Imaging Device UD-10

Basic Information

• Brand Name: Fully Automated Urine Particle Digital Imaging Device UD-10
• Primary DI: 04987562444779
• Version / Model: CJ445012
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-11
• Public Version: 3
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 0adcde7f-fb56-4223-b136-542b9f1ba1e2

Device Description

Fully Automated Urine Particle Digital Imaging Device UD-10

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
35918	Urine analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987562444779	GS1

Customer Contacts

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