Grafco

Basic Information

• Brand Name: Grafco
• Primary DI: M368339921
• Version / Model: 3399-2
• Catalog Number: 3399-2
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-05-10
• Public Version: 1
• Public Version Date: 2021-05-18
• Public Version Status: New
• Public Device Record Key: c58c4295-67e7-4dd6-897f-a38099cdf7ef

Device Description

TRACH TUBE BRUSH 4-1/2" F/00-4

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	868.5795	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34883	Airway device cleaning utensil, noninvasive, reusable	A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M368339920	HIBCC
Primary	M368339921	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]