BodyBox BB-00-01

GUDID 05407003160017

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

Medi Soft SA

Pulmonary function analysis system, adult

• Primary Device ID: 05407003160017
• NIH Device Record Key: a9214900-2021-4064-84e1-e7f31c447ff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyBox
• Version Model Number: DLCO He IB Si Std
• Catalog Number: BB-00-01
• 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 Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar
• Storage Environment Temperature: Between -45 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	05407003160017 [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