Invia Foam Dressing Kit

GUDID 07612367050029

Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs

Medela AG

Negative-pressure wound therapy system dressing set

• Primary Device ID: 07612367050029
• NIH Device Record Key: 56860bc1-832a-429e-85d0-8bdb3b90e75d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invia Foam Dressing Kit
• Version Model Number: 200.8905
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367050005 [Primary]
GS1	07612367050012 [Package]; Contains: 07612367050005; Package: [3 Units]; In Commercial Distribution
GS1	07612367050029 [Package]; Contains: 07612367050005; Package: [15 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 Foam Dressing Kit]

• 07612367050135: Invia Foam Dressing Kit with Fitpad - X-Large Sales number: 087.6224 3 PCs
• 07612367050111: Invia Foam Dressing Kit with Fitpad - Large Sales number: 087.6223 3 PCs / 087.6227 15 pcs
• 07612367050081: Invia Foam Dressing Kit with Fitpad - Medium Sales number: 087.6222 3 PCs / 087.6226 15 pcs
• 07612367050029: Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs