AccessGUDID - DEVICE: nSpire Health (00852417003408)

GUDID

Device Identifier (DI) Information

Brand Name: nSpire Health
Version or Model: KoKo Px 4000 Pulmonary Function System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PX4000
Company Name: NSPIRE HEALTH, INC.

Primary DI Number: 00852417003408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184817096 *Terms of Use

Device Description: Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance, and optional Maximum Pressures (MIP/MEP) tests.

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):	Yes
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?
35282	Pulmonary function analysis system, adult	A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZG	Spirometer, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030464	000

Device Exempt from Premarket Submission: No 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: 4a2b5a52-4305-4a92-b82d-70fe83309edc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016