The VitalCough®System

Basic Information

• Brand Name: The VitalCough®System
• Primary DI: 00887761997257
• Version / Model: M06829
• Company Name: HILL-ROM SERVICES PTE. LTD.
• Labeler DUNS: 595156263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cdb1252b-50ec-4613-9cfc-3459382c5809

Device Description

Respiratory Care

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHJ	DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38124	Chest-oscillation airway secretion-clearing system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761997257	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]