nSpire Health - Spirometry, Diffusion Capacity, and Nitrogen - NSPIRE HEALTH, INC.

Duns Number:184817096

Device Description: Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testi Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes 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, Multiple Breath Nitrogen Washout Lung Volumes, Maldistribution of Ventilation, Delta N2 & Closing Volume, and optional Maximum Pressures (MIP/MEP) tests.

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More Product Details

Catalog Number

PX3000

Brand Name

nSpire Health

Version/Model Number

KoKo Px 3000 Pulmonary Function Testing System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030917

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

c13ddcaf-f15f-4939-acdb-650e1848c2df

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NSPIRE HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 14