FDA.reportPublic FDA data

Volara System

Primary DI
10887761981499
Brand
Volara System
Company
HILL-ROM SERVICES PTE. LTD.
Model
M08473
Device description
Respiratory Care
Published
2020-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192143000Maximus SystemHill-Rom Services Pte, Ltd.2020-02-14NHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887761981499PackageGS15In Commercial Distribution
00887761981492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088776198149910887761981499
00887761981492008877619814928877619814920887761981492

GMDN Terms#

Term, Definition table
TermDefinition
In-exsufflatorA portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-3730us.customerservice@hillrom.com

Regulatory Flags#

DUNS number
595156263
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887761997318The VitalCough®SystemM065632016-09-17
00887761997325The VitalCough®SystemPVC12016-09-17
00887761008038The Vest APX SystemM08368A2026-03-18
00887761008045The Vest APX SystemM08368W2026-03-18
00887761976849The Vest®SystemP3006000052024-12-20
00887761984561Volara SystemM085732020-05-14
00887761985018Volara SystemM080852020-03-10
00887761967243The Vest APX SystemM084632024-09-06
00887761967366The Vest APX SystemM083682024-09-06
00887761967373The Vest APX SystemM083672024-09-06
00887761973473Life2000RMS010125CP2024-02-13
00887761974739Life2000BT-80-0008A2024-05-24
00887761981690Volara SystemM08594A2023-11-28
00887761978201Life2000BT-20-00022023-01-06
00887761984615Maximus SystemM082492020-03-06
00887761979048Life2000BT-80-00052024-02-13
00887761981492Volara SystemM084732020-03-04
00887761997608The Vest®SystemP3002810012016-09-17
00887761997332The MetaNeb®System1917742016-09-17
00887761997523The Vest®SystemP3002920012016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500501360228BiWaze Clear Dual Lumen Circuit With Face Mask - InfantAbmrc LLCNHJ2026-05-20
08500501360235BiWaze Clear Dual Lumen Circuit - AcuteAbmrc LLCNHJ2026-05-20
00887761008038The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
00887761008045The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
07321822320002ClearoBreas Medical ABNHJ2026-02-17
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-12-02
07321820104666Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
05060405720083ClearoBreas Medical ABNHJ2025-11-03
07321820081691ClearoBreas Medical ABNHJ2025-11-03
07321820082834ClearoBreas Medical ABNHJ2025-11-03
07321820090655ClearoBreas Medical ABNHJ2025-11-03
07321820090662ClearoBreas Medical ABNHJ2025-11-03
07321820090679ClearoBreas Medical ABNHJ2025-11-03
07321820106226Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-08-06
08809517011064Comfort CoughSeoil Pacific Corp.NHJ2025-02-19
00850018761383VOCSN Passive ValveVentec Life Systems, Inc.NHJ2024-12-02
00849436000730PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
10849436000737PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
00849436000709PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
00849436000716PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000706PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000713PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceAbmrc LLCNHJ2024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2024-04-01
08500501360068BiWaze Cough Dual Lumen Circuit With Face Mask - Adult LargeAbmrc LLCNHJ2024-04-01
00887761981690Volara SystemHILL-ROM SERVICES PTE. LTD.NHJ2023-11-28