TransAir3 10-SA-03-TA

GUDID 05407003162011

Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution

Medi Soft SA

Pulmonary function analysis system, adult

• Primary Device ID: 05407003162011
• NIH Device Record Key: 63359a1c-23dc-4d5e-b3a0-2c39995388fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransAir3
• Version Model Number: TransAir3
• Catalog Number: 10-SA-03-TA
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 800 millibar and 1200 millibar
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 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	05407003162011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953990

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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

Devices Manufactured by Medi Soft SA

• 05407003160017 - BodyBox: 2018-07-06 Body plethysmograph with DLCO He Dilution. Inspiratory bag. Standard Size. Pulmonary function testing, measuring lung volumes an
• 05407003160024 - BodyBox: 2018-07-06 Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing, measuring lung volumes and airw
• 05407003160031 - BodyBox: 2018-07-06 Body plethysmograph with DLCO He Dilution. Inspiratory bag. WheelChair Size. Pulmonary function testing, measuring lung volumes
• 05407003162011 - TransAir3: 2018-07-06Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution
• 05407003162011 - TransAir3: 2018-07-06 Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution
• 05407003163018 - SpiroAir: 2018-07-06 Rolling seal Spirometer, intended for measuring lung volumes by spirometry and Helium dilution