AccessGUDID - DEVICE: ACPlus Respiratory Assessment (00858703006344)

GUDID

Device Identifier (DI) Information

Brand Name: ACPlus Respiratory Assessment
Version or Model: ARASoftware
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006344
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: Software and sensor to provide assessment of respiratory capabilities.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	Exerciser, Non-Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c62d445-6cb9-4177-8568-adc70b3a7621
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023