Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit

Basic Information

• Brand Name: Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit
• Primary DI: 00848530089146
• Version / Model: NEB100-R
• Catalog Number: NEB100-R
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-11
• Public Version: 1
• Public Version Date: 2019-02-11
• Public Version Status: New
• Public Device Record Key: 9dd086bc-9cfb-44b7-aec9-946f5d0f8082

Device Description

Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62042	Nebulizing system delivery set, reusable	A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530089146	GS1

Customer Contacts

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