Synclara Cough System

GUDID 00887761984547

Respiratory Care

HILL-ROM SERVICES PTE. LTD.

In-exsufflator

• Primary Device ID: 00887761984547
• NIH Device Record Key: a2cf0c39-0512-4f35-82a6-fdbf9a708064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synclara Cough System
• Version Model Number: M08562
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887761984547 [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 [Synclara Cough System]

• 00887761984554: Respiratory Care
• 00887761995062: Respiratory Care
• 00887761984592: Respiratory Care
• 00887761984547: Respiratory Care
• 00887761985025: Respiratory Care
• 00887761984530: Respiratory Care
• 00887761975613: SYNCLARA SYSTEM, AC IRELAND
• 00887761975606: SYNCLARA SYSTEM, HC IRELAND
• 00887761975576: SYNCLARA, AC, IE
• 00887761975569: SYNCLARA, HC, IE