Volara System

Basic Information

• Brand Name: Volara System
• Primary DI: 00887761984561
• Version / Model: M08573
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Labeler DUNS: 595156263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-14
• Public Version: 2
• Public Version Date: 2023-12-19
• Public Version Status: Update
• Public Device Record Key: 5ea2baad-f317-4c47-a2ed-e0f21cf2acca

Device Description

VOLARA, AC NA

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NHJ	DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47152	Therapeutic positive pressure breathing ventilator	A mains electricity (AC-powered) device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patient's airways and lungs. It may be used in intermittent positive pressure breathing (IPPB) ventilation and temporary positive expiratory pressure (TPEP) modes providing aerosol therapy, respiratory exercises, and spray therapy. It is used in healthcare facilities or in the home typically for patients affected by abnormal production of secretions, asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761984561	GS1

Customer Contacts

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