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Volara System

FDA UDI

Class II (US FDA UDI)

by Hill-Rom Services Pte. Ltd.

Identity

Trade Name
Volara System FDA UDI
Generic Name
Therapeutic positive pressure breathing ventilator FDA UDI
Device Name
Respiratory Care FDA UDI
Model / Reference
M08087 FDA UDI
Description
Respiratory Care FDA UDI

Identifiers

Primary DI / UDI-DI
00887761984608 FDA UDI
FDA Product Code
NHJ FDA UDI
GMDN Term
Therapeutic positive pressure breathing ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Therapeutic positive pressure breathing ventilator

Volara System by Hill-Rom Services Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic positive pressure breathing ventilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hill-Rom Services Pte. Ltd.

Sources (1)

  • FDA UDI 3f52efa9-fb85-435d-b475-71003c931d11 34 fields · synced Jun 8, 2026