Volara System

Basic Information

• Brand Name: Volara System
• Primary DI: 00887761985018
• Version / Model: M08085
• 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: 2020-03-10
• Public Version: 2
• Public Version Date: 2020-05-18
• Public Version Status: Update
• Public Device Record Key: e55761f7-7b76-4966-b44d-8b4a4c83d748

Device Description

Respiratory Care

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
NHJ	DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37705	Ventilator breathing circuit, reusable	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761985018	GS1
Package	10887761985015	GS1		5	In Commercial Distribution

Customer Contacts

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