nSpire Health 815024

GUDID 00852417003651

KoKo Filter Sample Pack for KoKo Sx, KoKo Legend, KoKo DigiDoser and KoKo Trek.

NSPIRE HEALTH, INC.

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00852417003651
• NIH Device Record Key: b8a97b2a-84c2-4a65-81e9-02c1088fc5fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nSpire Health
• Version Model Number: KoKo Filter
• Catalog Number: 815024
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00852417003651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934475

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2016-09-16

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).