PARA-SED

Basic Information

• Brand Name: PARA-SED
• Primary DI: M445695ASAMPLE1
• Version / Model: 695A Sample
• Catalog Number: 695A Sample
• Company Name: MEDICAL CHEMICAL CORPORATION
• Labeler DUNS: 008496861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 60eea647-d1f6-45f6-9c41-4a00e4aea2c0

Device Description

PARA-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 10 sets of single use components.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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	M445695ASAMPLE1	HIBCC
Unit of Use	M445695ASAMPLE0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K941129	000