UTM-RT 302C.HL

GUDID 58053326008967

UTM - RT KIT Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens Double Plastic Applicators Polyester Tipped

COPAN ITALIA SPA

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 58053326008967
• NIH Device Record Key: b2205b56-f725-47ac-be0c-c77a833409e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTM-RT
• Version Model Number: 302C.HL
• Catalog Number: 302C.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	18053326008969 [Unit of Use]
GS1	38053326008963 [Primary]
GS1	58053326008967 [Package]; Contains: 38053326008963; 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