OxyTyke™

Basic Information

• Brand Name: OxyTyke™
• Primary DI: 10620974000522
• Version / Model: OTN-4025-8
• Catalog Number: OTN-4025-8
• Company Name: Southmedic Incorporated
• Labeler DUNS: 246848147
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 6
• Public Version Date: 2020-12-18
• Public Version Status: Update
• Public Device Record Key: 6e4f68a4-4e18-415a-b192-69bebd59f8ab
• Distribution End Date: 2020-12-18

Device Description

OxyTyke Nebulizer Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58810	Vortex oxygen face mask	A non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortices of high-concentration O2 directed to the mouth and nose to provide the full range of FiO2 (fraction of inspired oxygen) required for oxygen therapy. The fenestration designed to prevent positive pressure build-up and rebreathing, also allows for easier communication/feeding. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10620974000522	GS1
Unit of Use	00620974000525	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K760489	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			OxyTyke Nebulizer Kit