Personal Device Holder

Basic Information

• Brand Name: Personal Device Holder
• Primary DI: 00848530087777
• Version / Model: CSBD2Roller
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-19
• Public Version: 1
• Public Version Date: 2024-06-27
• Public Version Status: New
• Public Device Record Key: ce29d51f-2f70-44bb-bab5-dd99c042b829

Device Description

Cylinder Roller Bag — Dual D/E Tank

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64875	Home CPAP/BPAP washer/disinfector device container	A bag-like device intended for use with a home CPAP/BPAP washer/disinfector for the cleaning/disinfection of home positive airway pressure masks (e.g., CPAP/BPAP oral mask) using ozone gas as the disinfecting agent. It consists of a polymer receptacle that connects to the main washer/disinfector unit and in which the devices to be cleaned are placed for immersion in the cleaning medium; it includes an exhaust gas filter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530087777	GS1