Invia Fitpad

GUDID 07612367049610

Invia Fitpad sterile 10 PCs - 087.0028

Medela AG

Negative-pressure wound therapy tubing set

• Primary Device ID: 07612367049610
• NIH Device Record Key: 482fd36b-647f-4b4d-8858-fc93d173a5b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invia Fitpad
• Version Model Number: 200.7943
• 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	07612367049603 [Primary]
GS1	07612367049610 [Package]; Contains: 07612367049603; Package: [10 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

Devices Manufactured by Medela AG

• 07612367025133 - Docking Station Adapter for canister 2 L: 2024-06-11 Adapter to docking station for Thopaz canister 2L
• 07612367038713 - Standard rail universal holder: 2024-06-11 Universal clamp with standard rail
• 07612367000109 - Silicone tubing ID 6.5mm, 180cm, 1 coupling piece: 2024-06-10 Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
• 07612367003551 - Quiver 280mm: 2024-06-10 Quiver 280mm
• 07612367003568 - Quiver 480mm: 2024-06-10 Quiver 480mm
• 07612367003575 - Change over valve: 2024-06-10 Change over valve
• 07612367003698 - Overflow protection device: 2024-06-10 Overflow protection device
• 07612367003735 - Reusable serial connector: 2024-06-10 Reusable serial connector