FDA.reportPublic FDA data

Monarch™ System

Primary DI
00887761019867
Brand
Monarch™ System
Company
HILL-ROM SERVICES PTE. LTD.
Model
1000
Device description
Respiratory Care
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00887761981522PackageGS11In Commercial Distribution
00887761981539PackageGS11In Commercial Distribution
00887761981546PackageGS11In Commercial Distribution
00887761981553PackageGS11In Commercial Distribution
00887761981560PackageGS11In Commercial Distribution
00887761981577PackageGS11In Commercial Distribution
00887761981584PackageGS11In Commercial Distribution
00887761981591PackageGS11In Commercial Distribution
00887761981607PackageGS11In Commercial Distribution
00887761981614PackageGS11In Commercial Distribution
00887761981621PackageGS11In Commercial Distribution
00887761019867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761981522008877619815228877619815220887761981522
00887761981539008877619815398877619815390887761981539
00887761981546008877619815468877619815460887761981546
00887761981553008877619815538877619815530887761981553
00887761981560008877619815608877619815600887761981560
00887761981577008877619815778877619815770887761981577
00887761981584008877619815848877619815840887761981584
00887761981591008877619815918877619815910887761981591
00887761981607008877619816078877619816070887761981607
00887761981614008877619816148877619816140887761981614
00887761981621008877619816218877619816210887761981621
00887761019867008877610198678877610198670887761019867

GMDN Terms#

Term, Definition table
TermDefinition
Chest-oscillation airway secretion-clearing systemAn assembly of devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) oscillating pressurized air generator, an inflatable vest (jacket) to be worn by the patient and a connecting hose. It is intended to be operated by a healthcare professional in a professional setting.

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
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