Monarch™ System

GUDID 00887761019867

Respiratory Care

HILL-ROM SERVICES PTE. LTD.

Chest-oscillation airway secretion-clearing system

• Primary Device ID: 00887761019867
• NIH Device Record Key: 8a0ef9f0-eb94-4ff4-b825-e666dfcd2049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ System
• Version Model Number: 1000
• Company DUNS: 595156263
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761019867 [Primary]
GS1	00887761981522 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981539 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981546 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981553 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981560 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981577 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981584 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981591 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981607 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981614 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00887761981621 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• BYI: PERCUSSOR, POWERED-ELECTRIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-18
• Device Publish Date: 2017-05-08

Devices Manufactured by HILL-ROM SERVICES PTE. LTD.

• 00887761974739 - Life2000: 2024-06-03 Life 2000 Compressor
• 00887761981690 - Volara System: 2023-12-06 VOLARA, HC NA A
• 00887761978195 - Life2000: 2023-10-16 BREATHE LIFE2000 VENTILATOR PACKAGE HOSPITAL
• 00887761978201 - Life2000: 2023-10-16 LIFE2000 VENTILATOR PACKAGED
• 00887761975545 - Maximus System: 2021-12-10 MAXIMUS, HC, IE
• 00887761975552 - Maximus System: 2021-12-10 MAXIMUS, AC, IE
• 00887761975569 - Synclara Cough System: 2021-12-10 SYNCLARA, HC, IE
• 00887761975576 - Synclara Cough System: 2021-12-10 SYNCLARA, AC, IE