FecalSwab™ 4C028S

GUDID 38053326000257

FecalSwab 2ml + rectal FLOQSwab with plastic ring

COPAN ITALIA SPA

Rectal/faecal specimen collection kit Rectal/faecal specimen collection kit Rectal/faecal specimen collection kit Rectal/faecal specimen collection kit

• Primary Device ID: 38053326000257
• NIH Device Record Key: 5867bfc1-d447-4ce6-94b7-cc1a17683ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FecalSwab™
• Version Model Number: 4C028S
• Catalog Number: 4C028S
• 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	18053326000253 [Unit of Use]
GS1	28053326000250 [Primary]
GS1	38053326000257 [Package]; Contains: 28053326000250; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142094

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [FecalSwab™ ]

• 58053326002194: FecalSwab™ Collection Kit
• 38053326000301: 1 LQ AMIES TEST TUBE+2 PINK APPLICATORS+1 WHITE APPLICATOR
• 38053326000257: FecalSwab 2ml + rectal FLOQSwab with plastic ring