Thopaz 200.2219

GUDID 07612367017480

Thoracic suction system pump 079.0002

Medela AG

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• Primary Device ID: 07612367017480
• NIH Device Record Key: c704fe5a-aa23-4d52-a69a-69e3210f8363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thopaz
• Version Model Number: Thopaz
• Catalog Number: 200.2219
• Company DUNS: 488293218
• Company Name: Medela AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367017480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130210

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

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: 2016-10-03

On-Brand Devices [Thopaz]

• 07612367017497: Thoracic suction system pump 079.0003
• 07612367017480: Thoracic suction system pump 079.0002
• 07612367014205: Thoracic Vacuum Pump 079.0000