Asthma Monitor AM3

GUDID 04057155000207

Asthma Monitor, electronic peak flow meter with TCP/IP

eResearchTechnology GmbH

Peak flow meter, electronic

• Primary Device ID: 04057155000207
• NIH Device Record Key: 896a87cb-8905-4c9d-87fa-b43686489d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asthma Monitor AM3
• Version Model Number: AM3 G+
• 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: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183479

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [Asthma Monitor AM3]

• 04057155000191: Asthma Monitor, electronic peak flow meter
• 04057155000207: Asthma Monitor, electronic peak flow meter with TCP/IP