BD FCT

Basic Information

• Brand Name: BD FCT
• Primary DI: 38053326011826
• Version / Model: 445388
• Catalog Number: 445388
• Company Name: COPAN ITALIA SPA
• Labeler DUNS: 428981112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-01-26
• Public Version: 1
• Public Version Date: 2026-02-03
• Public Version Status: New
• Public Device Record Key: 9b66b5c6-7f07-411b-b6e3-4051e181533e

Device Description

BD FCT - Stool collection and preservation, 2 mL + regular flocked swab

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	58053326011820	GS1		6	In Commercial Distribution
Primary	38053326011826	GS1
Unit of Use	18053326011822	GS1

Premarket Submissions

Submission Number	Supplement Number
K142094	000