Invia Gauze Dressing Kit

GUDID 07612367050180

Invia Gauze Dressing Kit with FitPad - Large - 087.7171 3pcs

Medela AG

Negative-pressure wound therapy system dressing set

• Primary Device ID: 07612367050180
• NIH Device Record Key: a91a6940-448c-45cd-8c10-d5e403d1ecc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invia Gauze Dressing Kit
• Version Model Number: 200.8910
• 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	07612367050173 [Primary]
GS1	07612367050180 [Package]; Contains: 07612367050173; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170088

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-07

On-Brand Devices [Invia Gauze Dressing Kit]

• 07612367050180: Invia Gauze Dressing Kit with FitPad - Large - 087.7171 3pcs
• 07612367050166: Invia Gauze Dressing Kit with Fitpad - Medium 087.7170 3 pcs / 087.7172 15 pcs