Volara System

GUDID 00887761984578

Respiratory Care

HILL-ROM SERVICES PTE. LTD.

Therapeutic positive pressure breathing ventilator

• Primary Device ID: 00887761984578
• NIH Device Record Key: f913aa4f-2a86-45f7-bb93-888082f5cf13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volara System
• Version Model Number: M08594
• Company DUNS: 595156263
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761984578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192143

FDA Product Code

• NHJ: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-03-01

On-Brand Devices [Volara System]

• 00887761984578: Respiratory Care
• 00887761984622: Respiratory Care
• 10887761981499: Respiratory Care
• 00887761984608: Respiratory Care
• 00887761985018: Respiratory Care
• 00887761984561: VOLARA, AC NA
• 00887761977426: VOLARA SYSTEM, AC UK-IRELAND
• 00887761977419: VOLARA SYSTEM, HC UK-IRELAND
• 00887761981690: VOLARA, HC NA A