Shusher Care

Basic Information

• Brand Name: Shusher Care
• Primary DI: 00850024829367
• Version / Model: SH-NEB
• Company Name: PENO LLC
• Labeler DUNS: 828917653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-03
• Public Version: 1
• Public Version Date: 2025-11-11
• Public Version Status: New
• Public Device Record Key: 327d3afd-069c-45e4-9225-4f1130b0cf6d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• 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
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	868.5640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850024829367	GS1