EZCare™ Softouch

Basic Information

• Brand Name: EZCare™ Softouch
• Primary DI: 10812594012249
• Version / Model: 11" Pink
• Catalog Number: N9111PK
• Company Name: Neotech Products LLC
• Labeler DUNS: 198013435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-06-15
• Public Version: 5
• Public Version Date: 2023-09-19
• Public Version Status: Update
• Public Device Record Key: 8307f446-f9ef-47c0-8f1c-82ea6c3a9992

Device Description

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63438	Tracheostomy tube neck holder, single-use	A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00812594012242	GS1
Primary	10812594012249	GS1