Detergent for Automatic Urine Analyzer

Basic Information

• Brand Name: Detergent for Automatic Urine Analyzer
• Primary DI: 06935740750639
• Version / Model: URIT D21N,500mL
• Company Name: Urit Medical Electronic Co., Ltd.
• Labeler DUNS: 653742429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-16
• Public Version: 1
• Public Version Date: 2026-04-24
• Public Version Status: New
• Public Device Record Key: c5d1d542-b8c4-44ec-bb27-0d948482b3ea

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JCB	Detergent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63377	Instrument/analyser cleaning agent IVD	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to in vitro diagnostic devices (e.g., analysers, laboratory instruments, other types of laboratory devices) for pre-cleaning and/or cleaning to remove organic compounds such as blood proteins prior to disinfection or sterilization. It is typically loaded on-board automated or semi-automated instruments for internal cleaning. It typically includes a detergent, and some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06935740750639	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius