Spirowin

GUDID 03760253450010

FIM MEDICAL

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• Primary Device ID: 03760253450010
• NIH Device Record Key: c631dea3-7b4f-4e4d-a1a9-43e3aaf9580f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirowin
• Version Model Number: Expert
• 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: true
• 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
• 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	03760253450010 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-17
• Device Publish Date: 2017-05-04

On-Brand Devices [Spirowin ]

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