KoKo, LLC 700971

GUDID 00852417003514

All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convienence.

Koko, LLC

Whole-body plethysmograph

• Primary Device ID: 00852417003514
• NIH Device Record Key: 16a6b8b8-0a78-4b70-8ced-ac7559ae4be3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KoKo, LLC
• Version Model Number: KoKo PX4000 Plethysmograph
• Catalog Number: 700971
• 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	00852417003514 [Primary]

FDA Product Code

• CCM: Plethysmograph, Pressure

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: 2021-04-26
• Device Publish Date: 2021-04-16

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