Invia White Foam NPWT

GUDID 07612367057493

PVA foam dressing - small

Medela AG

Negative-pressure wound therapy system dressing set

• Primary Device ID: 07612367057493
• NIH Device Record Key: ece50a7a-70d6-45a2-8adc-968a77eaf8ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invia White Foam NPWT
• Version Model Number: 087.6303
• Company DUNS: 488293218
• Company Name: Medela AG
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367057493 [Primary]
GS1	07612367057516 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180415

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-27
• Device Publish Date: 2018-11-26

On-Brand Devices [Invia White Foam NPWT]

• 07612367057509: PVA foam dressing - large
• 07612367057493: PVA foam dressing - small