SPIROWIN

GUDID 03760253450621

FIM MEDICAL

Pulmonary function analysis system, adult

• Primary Device ID: 03760253450621
• NIH Device Record Key: fe45fc44-c140-4982-bdee-e1726090d786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIROWIN
• Version Model Number: EXPERT DEPISTEO
• Company DUNS: 577219207
• Company Name: FIM MEDICAL
• 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: false
• 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

Customer Support Contacts

• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com
• Phone: +33(0)472343031
• Email: joanna.corre@depisteo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760253450621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161676

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2023-07-13
• Device Publish Date: 2023-07-05

On-Brand Devices [SPIROWIN ]

• 03760253450010: Expert
• 03760253450607: EXPERT DEPISTEO
• 03760253450621: EXPERT DEPISTEO
• 03760253450614: Expert