FlowScreen

GUDID 04057155000139

diagnostic spirometer for recording and assessing pulmonary function

eResearchTechnology GmbH

Diagnostic spirometer

• Primary Device ID: 04057155000139
• NIH Device Record Key: 585db9e8-e5ef-4f15-b2a9-0c60c0f38c48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowScreen
• Version Model Number: FlowScreen
• Company DUNS: 341625331
• Company Name: eResearchTechnology GmbH
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080734

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [FlowScreen]

• 04057155000139: diagnostic spirometer for recording and assessing pulmonary function
• 04057155000122: diagnostic spirometer for recording and assessing pulmonary function