Caplugs/Evergreen

Basic Information

• Brand Name: Caplugs/Evergreen
• Primary DI: 00810044208153
• Version / Model: 308-1050-FPCSV
• Catalog Number: 308-1050-FPCSV
• Company Name: CAPlugs
• Labeler DUNS: 098203461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-31
• Public Version: 2
• Public Version Date: 2026-04-23
• Public Version Status: Update
• Public Device Record Key: d714dfdd-fc79-4147-a9c0-6b329d48bc4c

Device Description

FECAL PARASITE CONC SPECIAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKS	Device, parasite concentration	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57939	Faecal parasite specimen concentration kit IVD	A collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810044208153	GS1

Customer Contacts

• Phone: [phone] ext. 3241
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K833469	000