Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR, Sterile

Basic Information

• Brand Name: Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR, Sterile
• Primary DI: 00840117344129
• Version / Model: 31004
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-27
• Public Version: 1
• Public Version Date: 2025-11-04
• Public Version Status: New
• Public Device Record Key: 73865195-6e1b-479d-bd07-e2f1e1d1c094

Device Description

3.3 mm (10 FR), 12 in (30.5 cm), STERILE-EO, T-Piece, Tracheal, Adult/Pediatric.

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: Yes
• 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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34041	Tracheobronchial suction/insufflation catheter, single-lumen	A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840117343955	GS1	Box	10	In Commercial Distribution
Primary	00840117344129	GS1
Package	00840117343795	GS1	Case	2	In Commercial Distribution