Q13 DEPISTEO Spirolyser

GUDID 03760253450522

FIM MEDICAL

Pulmonary function analysis system, adult

• Primary Device ID: 03760253450522
• NIH Device Record Key: 57370a71-4769-4268-96bc-ca2d6cb22cc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q13 DEPISTEO Spirolyser
• Version Model Number: FF1153 Q13 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: true
• Manufacturing Date: true
• 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: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com
• Phone: +33472123693
• Email: d.benbachir@fim-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760253450522 [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: 2021-12-08
• Device Publish Date: 2021-11-30

Devices Manufactured by FIM MEDICAL

• 03760253450638 - Ergofilter: 2023-09-12 accessory to active diagnostic devices: FIM Spirometers
• 03760253450645 - Ergofilter: 2023-09-12 accessory to active diagnostic devices: FIM Spirometers
• 03760253450614 - SPIROWIN: 2023-07-13
• 03760253450621 - SPIROWIN: 2023-07-13
• 03760253450577 - VT1: 2022-06-15
• 03760253450157 - VT1: 2022-06-09
• 03760253450249 - VT1: 2022-06-09
• 03760253450607 - SPIROWIN: 2022-03-24