nSpire Health 400600

GUDID 00852417003453

Spirometry and Diffusion Capacity 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 and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

Pulmonary function analysis system, adult
Primary Device ID00852417003453
NIH Device Record Key62ff938a-c175-4baa-908d-1141309687ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamenSpire Health
Version Model NumberKoKo Px 2000 Pulmonary Function Test System
Catalog Number400600
Company DUNS184817096
Company NameNSPIRE HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852417003453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-14

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