The Vest APX System

Basic Information

• Brand Name: The Vest APX System
• Primary DI: 00887761967243
• Version / Model: M08463
• 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: 2024-09-06
• Public Version: 1
• Public Version Date: 2024-09-16
• Public Version Status: New
• Public Device Record Key: f1bfcb0f-c893-4860-ad2d-f132893a8da5

Device Description

The Vest APX Control Unit (High Frequency Chest Wall Oscillation Device)

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
BYI	PERCUSSOR, POWERED-ELECTRIC	Anesthesiology	868.5665	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	00887761967243	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal