FDA.reportPublic FDA data

Maximus System

Primary DI
00887761984615
Brand
Maximus System
Company
HILL-ROM SERVICES PTE. LTD.
Model
M08249
Device description
Respiratory Care
Published
2020-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00887761984615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761984615008877619846158877619846150887761984615

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video imaging electrical interface setA combination of electrical devices intended to electrically connect/interface two or more endoscopic video imaging system subunits. It includes an electrical cable(s), an interface unit, and may typically include additional supportive accessories (e.g., equipment fixation underpad); it does not include any image processing/recording devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
595156263
Device count
1
Serial number
true
Manufacturing date on label
true

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
00887761979048Life2000BT-80-00052024-02-13
00887761981492Volara SystemM084732020-03-04
00887761997608The Vest®SystemP3002810012016-09-17
00887761997332The MetaNeb®System1917742016-09-17
00887761997523The Vest®SystemP3002920012016-09-17
00887761997844The Vest®System5003700062016-09-17

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