Resp-O2 Closed Suction Tracheostomy Catheter

Basic Information

• Brand Name: Resp-O2 Closed Suction Tracheostomy Catheter
• Primary DI: 00840117319486
• Version / Model: 31013
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-04-22
• Public Version: 1
• Public Version Date: 2021-04-30
• Public Version Status: New
• Public Device Record Key: 520863b2-4944-4696-8f8c-bcf0e2c5304b

Device Description

Resp-O2 Closed Suction Tracheostomy Catheter, 16FR with Double Swivel Elbow, Adult

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: MR Unsafe
• 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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63465	Closed-suction breathing circuit connector/switch	A sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840117319493	GS1	Case	2	In Commercial Distribution
Primary	00840117319486	GS1
Unit of Use	00840117319721	GS1