Resp-O2 Tracheostomy Gauze Sponges

Basic Information

• Brand Name: Resp-O2 Tracheostomy Gauze Sponges
• Primary DI: 00840117309845
• Version / Model: 35051
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-05-02
• Public Version: 1
• Public Version Date: 2022-05-10
• Public Version Status: New
• Public Device Record Key: 14ec36d4-8072-401d-97d7-e8b7f5899cc3

Device Description

Resp-O2 Tracheostomy Gauze Sponges, Sterile, 100% Cotton, 4" x 4", 12-Ply, 2 per pouch

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15624	Tracheostomy tube dressing	A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. 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	00840117322653	GS1
Primary	00840117309845	GS1
Package	00840117309852	GS1	Case	6	In Commercial Distribution