Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl Gloves

Basic Information

• Brand Name: Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl Gloves
• Primary DI: 00840117309685
• Version / Model: 35001
• 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: 3b85314b-3843-4b14-b14d-61c44b811298

Device Description

(1) Three-compartment tray (1) Pair of vinyl gloves (1) 3-Ply waterproof drape (4) Non-woven gauze, 4" × 4" (1) Tracheostomy dressing (2) Cotton-tipped applicators (1) Twill tape (2) Pipe cleaners (1) Tracheostomy brush

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	00840117309685	GS1
Package	00840117309692	GS1	Case	20	In Commercial Distribution