MEDI-CHOICE

Basic Information

• Brand Name: MEDI-CHOICE
• Primary DI: B150TRAC10010
• Version / Model: TRAC1001
• Company Name: NURSE ASSIST, INC.
• Labeler DUNS: 869434464
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-14
• Public Version: 4
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 050a7ed9-eb1c-4aac-a406-23db674bcf77

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B150TRAC10010	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K842166	000