ACPlus Respiratory Assessment

Basic Information

• Brand Name: ACPlus Respiratory Assessment
• Primary DI: 00858703006344
• Version / Model: ARASoftware
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: 8c62d445-6cb9-4177-8568-adc70b3a7621

Device Description

Software and sensor to provide assessment of respiratory capabilities.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66879	Pulmonary function analysis software, interpretive	An interpretive software program intended to be used on a non-medical computerized device to analyse data captured during pulmonary function testing/analysis (e.g., carbon dioxide breath analysis) and provide a definitive diagnosis of a cardiorespiratory condition for evaluation by a healthcare professional. It typically utilizes artificial intelligence (AI) and machine learning techniques.	No	Active
13680	Diagnostic spirometer, professional	An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858703006344	GS1

Customer Contacts

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