KoKo, LLC PX3000

GUDID 00852417003491

Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusion 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.

Koko, LLC

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• Primary Device ID: 00852417003491
• NIH Device Record Key: d1e817b6-7956-4b8c-805d-996b5ef43278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KoKo, LLC
• Version Model Number: KoKo Px 3000 Pulmonary Function Testing System
• Catalog Number: PX3000
• Company DUNS: 117528917
• Company Name: Koko, LLC
• 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	00852417003491 [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: 2020-12-14
• Device Publish Date: 2020-12-05

On-Brand Devices [KoKo, LLC]

• 00852417003491: Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testing Sys
• 00852417003514: All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release o
• 00852417003507: Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes and Plethysmography Pulmonary Func