nSpire Health 313120

GUDID 00852417003316

KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on a single computer without access to an Iris central database.

NSPIRE HEALTH, INC.

Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 00852417003316
• NIH Device Record Key: 2ecc32cc-8f9a-4e5d-9e5e-f92bd7f7e314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nSpire Health
• Version Model Number: KoKo Sx 1000 Diagnostic Spirometer Standalone Edit
• Catalog Number: 313120
• 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	00852417003316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914272

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-24

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• 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
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• 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
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• 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).