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Monarch™ System

FDA UDI

Class II (US FDA UDI)

by Hill-Rom Services Pte. Ltd.

Identity

Trade Name
Monarch™ System FDA UDI
Generic Name
Chest-oscillation airway secretion-clearing system vest FDA UDI
Device Name
MONARCH MODEL 1000 ACS,IRELAND FDA UDI
Model / Reference
PMACS1IE FDA UDI
Description
MONARCH MODEL 1000 ACS,IRELAND FDA UDI

Identifiers

Primary DI / UDI-DI
00887761977495 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Chest-oscillation airway secretion-clearing system vest FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Chest-oscillation airway secretion-clearing system vest

Monarch™ System by Hill-Rom Services Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chest-oscillation airway secretion-clearing system vest.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hill-Rom Services Pte. Ltd.

Sources (1)

  • FDA UDI 830cd034-0f10-46c2-a0be-1532a2e4da63 34 fields · synced May 30, 2026