FecalSwab™

Basic Information

• Brand Name: FecalSwab™
• Primary DI: 28053326000250
• Version / Model: 4C028S
• Catalog Number: 4C028S
• Company Name: COPAN ITALIA SPA
• Labeler DUNS: 428981112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 5867bfc1-d447-4ce6-94b7-cc1a17683ca0

Device Description

FecalSwab 2ml + rectal FLOQSwab with plastic ring

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: Yes
• 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
65197	Rectal/faecal specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, spatula], and a covered receptacle with or without an additive/medium (e.g., cell or nucleic acid preservation solution, Carey-Blair transport 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	38053326000257	GS1		10	In Commercial Distribution
Primary	28053326000250	GS1
Unit of Use	18053326000253	GS1

Premarket Submissions

Submission Number	Supplement Number
K142094	000