eNAT® 6U072S

GUDID 58053326009681

COPAN ITALIA SPA

General specimen container IVD, preservation solution

• Primary Device ID: 58053326009681
• NIH Device Record Key: 9adfcd41-179c-427c-b5c1-5971e9ff594c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eNAT®
• Version Model Number: 6U072S
• Catalog Number: 6U072S
• 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	08053326009686 [Unit of Use]
GS1	38053326009687 [Primary]
GS1	58053326009681 [Package]; Contains: 38053326009687; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201849

FDA Product Code

• QBD: Microbial Nucleic Acid Storage And Stabilization Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-24
• Device Publish Date: 2021-02-16

On-Brand Devices [eNAT®]

• 58053326009704: 6U074S01
• 58053326009698: 6U073S01
• 58053326009681: 6U072S