Roscoe Medical

Basic Information

• Brand Name: Roscoe Medical
• Primary DI: 00092237603161
• Version / Model: NEB-ROS
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-04
• Public Version: 4
• Public Version Date: 2023-08-24
• Public Version Status: Update
• Public Device Record Key: 9b19cf54-f66a-423f-89e2-ab6c8a43b5ae
• Distribution End Date: 2019-05-07

Device Description

Roscoe Mini Neb Compressor and

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
66295	Ambulatory nebulizer, non-heated	An electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00092237603161	GS1
Package	60092237603163	GS1	PK	3	Not in Commercial Distribution	2019-05-07
Package	80092237603167	GS1	CA	2	Not in Commercial Distribution	2019-05-07

Customer Contacts

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