Copan Universal Transport Medium (UTM-RT) System

Basic Information

• Brand Name: Copan Universal Transport Medium (UTM-RT) System
• Primary DI: 38053326011079
• Version / Model: 3C085N01
• Catalog Number: 3C085N01
• Company Name: COPAN ITALIA SPA
• Labeler DUNS: 428981112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2025-05-28
• Public Version: 1
• Public Version Date: 2025-06-05
• Public Version Status: New
• Public Device Record Key: 53b792f8-9952-4dc7-9978-d50a441f8856

Device Description

Copan Universal Transport Medium (UTM-RT) System 3ml + One minitip flocked swab, breaking point 80 mm

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1
LIO	Device, Specimen Collection	Microbiology	866.2900	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
Package	58053326011073	GS1		6	In Commercial Distribution
Primary	38053326011079	GS1
Unit of Use	08053326010446	GS1