Ergofilter

GUDID 03760253450638

accessory to active diagnostic devices: FIM Spirometers

FIM MEDICAL

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 03760253450638
• NIH Device Record Key: 5589bc4e-df0b-427a-b74b-63f409049abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergofilter
• Version Model Number: SP1
• Company DUNS: 577219207
• Company Name: FIM MEDICAL
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760253450638 [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: 2023-09-12
• Device Publish Date: 2023-09-04

On-Brand Devices [Ergofilter]

• 03760253450645: accessory to active diagnostic devices: FIM Spirometers
• 03760253450638: accessory to active diagnostic devices: FIM Spirometers