RenalytixAI Urine Collection Kit

Basic Information

• Brand Name: RenalytixAI Urine Collection Kit
• Primary DI: 00196852375677
• Version / Model: RENX3011003
• Company Name: Renalytix Ai, Inc.
• Labeler DUNS: 117063935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-06
• Public Version: 2
• Public Version Date: 2023-02-28
• Public Version Status: Update
• Public Device Record Key: 75f43196-36e1-4eb8-9cb5-1f045d969a82

Device Description

Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00196852375677	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius