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 ID: 00852417003453
• NIH Device Record Key: 62ff938a-c175-4baa-908d-1141309687ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nSpire Health
• Version Model Number: KoKo Px 2000 Pulmonary Function Test System
• Catalog Number: 400600
• Company DUNS: 184817096
• Company Name: NSPIRE HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852417003453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030917

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

On-Brand Devices [nSpire Health]

• 00852417003651: KoKo Filter Sample Pack for KoKo Sx, KoKo Legend, KoKo DigiDoser and KoKo Trek.
• 00852417003484: Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes and Plethysmography Pulmonary Func
• 00852417003477: Spirometry, Diffusion Capacity and Plethysmography Pulmonary Function Testing System. Performs
• 00852417003460: Spirometry, Diffusion Capacity and Nitrogen Washout Lung Volumes Pulmonary Function Testing Syst
• 00852417003453: Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spi
• 00852417003446: All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release o
• 00852417003415: All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release o
• 00852417003408: Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs
• 00852417003392: Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testing Sys
• 00852417003385: Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spir
• 00852417003361: KoKo Legend II Spirometer (without printer)
• 00852417003354: KoKo Legend II Spirometer (with printer)
• 00852417003347: KoKo Sx 1000 spirometer and software package, fully compatible with Iris server to allow support
• 00852417003316: KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on
• 00852417003118: Bronchial Challenge Kit, Disposable (single patient use).