Maximus System

GUDID 00887761984585

MAXIMUS, NA

HILL-ROM SERVICES PTE. LTD.

In-exsufflation/lung-oscillation airway secretion-clearing system

• Primary Device ID: 00887761984585
• NIH Device Record Key: 657eb6f6-9a08-4413-9f2c-8743f980667b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maximus System
• Version Model Number: M08558
• Company DUNS: 595156263
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com
• Phone: +1(800)445-3730
• Email: us.customerservice@hill-rom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761984585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192143

FDA Product Code

• NHJ: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Maximus System]

• 00887761984585: MAXIMUS, NA
• 00887761984615: Respiratory Care
• 00887761975590: MAXIMUS SYSTEM, AC IRELAND
• 00887761975583: MAXIMUS SYSTEM, HC IRELAND
• 00887761975552: MAXIMUS, AC, IE
• 00887761975545: MAXIMUS, HC, IE