Volara System

GUDID 00887761981690

VOLARA, HC NA A

HILL-ROM SERVICES PTE. LTD.

Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator Therapeutic positive pressure breathing ventilator
Primary Device ID00887761981690
NIH Device Record Key284d832d-0ee0-45c1-a62e-55032a4c9de8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVolara System
Version Model NumberM08594A
Company DUNS595156263
Company NameHILL-ROM SERVICES PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com
Phone+1(800)445-3730
Emailus.customerservice@hill-rom.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887761981690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-06
Device Publish Date2023-11-28

On-Brand Devices [Volara System]

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

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