Holder with standard rail

GUDID 07612367016339

Holder with standard rail for attachment of powered suction pump (e.g Invia Liberty or Thopaz)

Medela AG

Medical device service rail clamp

• Primary Device ID: 07612367016339
• NIH Device Record Key: 3c771051-7efe-4850-a31e-83b79761c7d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holder with standard rail
• Version Model Number: 079.0036
• 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: false
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367016339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142626

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

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

Devices Manufactured by Medela AG

• 07612367089289 - Invia Liberty Carrying Case: 2024-10-21
• 07612367024518 - Invia Motion Carrying Case: 2024-10-21
• 07612367053136 - Invia Liberty: 2024-08-30 Negative Pressure Wound Therapy Powered Suction Pump - 087.0003
• 07612367053143 - Invia Motion 15 Days NPWT: 2024-08-30 Negative Pressure Wound Therapy Powered Suction Pump - 087.4022
• 07612367053150 - Invia Motion 60 Days NPWT: 2024-08-30 Negative Pressure Wound Therapy Powered Suction Pump - 087.4024
• 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