BodyBox BB-00-02

GUDID 05407003160024

Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing, measuring lung volumes and airway resistance by spiro

Medi Soft SA

Pulmonary function analysis system, adult

• Primary Device ID: 05407003160024
• NIH Device Record Key: 959d9525-3379-4c60-a06e-5751e1c7d838
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyBox
• Version Model Number: DLCO He IB Si XL
• Catalog Number: BB-00-02
• Company DUNS: 393789540
• Company Name: Medi Soft SA
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -45 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05407003160024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022636

FDA Product Code

• JEH: Plethysmograph, Volume

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: 2016-09-15

On-Brand Devices [BodyBox]

• 05407003160031: Body plethysmograph with DLCO He Dilution. Inspiratory bag. WheelChair Size. Pulmonary function
• 05407003160024: Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing,
• 05407003160017: Body plethysmograph with DLCO He Dilution. Inspiratory bag. Standard Size. Pulmonary function te