7500 V MASK

Basic Information

• Brand Name: 7500 V MASK
• Primary DI: 00874750000647
• Version / Model: 7500
• Catalog Number: 669150
• Company Name: HANS RUDOLPH, INC.
• Labeler DUNS: 007131725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-05
• Public Version: 1
• Public Version Date: 2023-04-13
• Public Version Status: New
• Public Device Record Key: 5bff577d-22f3-4292-adbc-72932f7658e7

Device Description

LARGE FACE MASK 7500

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57814	CPAP/BPAP face mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00874750000647	GS1

Premarket Submissions

Submission Number	Supplement Number
K030515	000