Oxygen Kit

Basic Information

• Brand Name: Oxygen Kit
• Primary DI: 00848530096625
• Version / Model: RESO2KITB
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-03
• Public Version: 1
• Public Version Date: 2024-06-11
• Public Version Status: New
• Public Device Record Key: 1a577ea0-7677-4a93-9692-5ba9f0f714b8

Device Description

(6) RES1100S (2) RES1107S (1) RES3025 (1)RES3050 (1)RES003 (1) RES002 (1)RES032 (1) RES018

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: No
• 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
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60856	Oxygen administration kit	A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530096625	GS1

Customer Contacts

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