Deluxe Closed Suction System

Basic Information

• Brand Name: Deluxe Closed Suction System
• Primary DI: 00848530095123
• Version / Model: VEN160120M
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-28
• Public Version: 1
• Public Version Date: 2024-06-05
• Public Version Status: New
• Public Device Record Key: edea8bdb-9a72-445e-b1dd-42a4e9363e14

Device Description

"Deluxe CSS, Adult, 24-hours, Endotracheal, 540mm, MDI Port, 12Fr,1-hand switch,sterile,latex-free

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: No
• MRI Safety: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11052	Cricothyrotome, single-use	A sterile, hand-held, manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530095123	GS1

Customer Contacts

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