Resp-O2 Tracheostomy Care Kit, 1-Compartment Mini-Tray

Basic Information

• Brand Name: Resp-O2 Tracheostomy Care Kit, 1-Compartment Mini-Tray
• Primary DI: 00840117321410
• Version / Model: 35009
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-03
• Public Version: 1
• Public Version Date: 2022-10-11
• Public Version Status: New
• Public Device Record Key: 5cf8da48-a623-4a68-a59c-998b59b15390

Device Description

(1) One-compartment mini-tray (2) Non-woven gauze, 4" × 4" (2) Tracheostomy dressing (2) Cotton-tipped applicators (2) Pipe cleaners (1) Hydrogen peroxide 1 oz. pack

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown		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	00840117321410	GS1
Package	00840117321489	GS1	Case	40	In Commercial Distribution