FDA.reportPublic FDA data

Monarch™ System

Primary DI
00887761977495
Brand
Monarch™ System
Company
HILL-ROM SERVICES PTE. LTD.
Model
PMACS1IE
Device description
MONARCH MODEL 1000 ACS,IRELAND
Published
2021-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPERCUSSOR, POWERED-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761977495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761977495008877619774958877619774950887761977495

GMDN Terms#

Term, Definition table
TermDefinition
Chest-oscillation airway secretion-clearing system vestA tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.

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
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
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
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00816305024906AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024913AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
30889483563117BALLARD™SUNMED, LLCBYI2025-12-01
00606959420540inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420557inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420564inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420571inCourage®Respiratory Technologies, Inc.BYI2025-09-17
B102090700S0100SmartVestELECTROMED, INC.BYI2025-07-02
07290020062000LibAirty Airway Clearance SystemSYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062017LibAirty Airway Clearance System Vest (S)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062024LibAirty Airway Clearance System Vest (M)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062031LibAirty Airway Clearance System Vest (L)SYNCHRONY MEDICAL LTDBYI2025-05-19
B102125003S0110SmartVestELECTROMED, INC.BYI2025-03-19
B102125003S0311SmartVestELECTROMED, INC.BYI2025-01-21
B102125003S0411SmartVestELECTROMED, INC.BYI2025-01-21
00887761976849The Vest®SystemHILL-ROM SERVICES PTE. LTD.BYI2024-12-20
00887761967243The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06
00887761967366The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06