Roscoe Medical

Basic Information

• Brand Name: Roscoe Medical
• Primary DI: 00092237624326
• Version / Model: RITE-NEB5-REUS
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-25
• Public Version: 2
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: 69364955-696f-4a26-965a-4d37803a5b5a

Device Description

Roscoe Rite-Neb 5 Nebulizer Compressor w/ Disposable Neb Kit & Reus Neb Kit included

Device Characteristics

• Single Use: No
• 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: 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
Package	80092237624322	GS1		6	In Commercial Distribution
Primary	00092237624326	GS1

Customer Contacts

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