UTM-RT 3C030N.HL

GUDID 58053326009117

UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens

COPAN ITALIA SPA

General specimen container IVD, additive/medium

• Primary Device ID: 58053326009117
• NIH Device Record Key: 65b387fc-9a29-4a2d-a56a-efe894b7d765
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTM-RT
• Version Model Number: 3C030N.HL
• Catalog Number: 3C030N.HL
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08053326009112 [Unit of Use]
GS1	38053326009113 [Primary]
GS1	58053326009117 [Package]; Contains: 38053326009113; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [UTM-RT ]

• 58053326008974: UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
• 38053326002848: Medium + 2 Regular Polyester sterile Swabs
• 28053326003077: UTM MINI 1ML IN BULK Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimen
• 28053326002964: UTM 3ML W/O APPL. Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
• 58053326009117: UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens
• 58053326008981: UTM - RT KIT Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens Regular Flocked Sw
• 58053326008967: UTM - RT KIT Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens Double Plastic App