Pipette

GUDID 03760253450263

FIM MEDICAL

Breathing mouthpiece, single-use

• Primary Device ID: 03760253450263
• NIH Device Record Key: 773557f0-4ebb-4405-90bd-fc069c605da5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pipette
• Version Model Number: Pipette
• Company DUNS: 577219207
• Company Name: FIM MEDICAL
• Device Count: 500
• 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: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com
• Phone: +3(0)672559096
• Email: joanna.corre@depisteo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760253450263 [Primary]
GS1	03760253450362 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080278

FDA Product Code

• CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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: 2020-03-23
• Device Publish Date: 2017-09-15

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