Adapter Vario

GUDID 07612367015387

Adapter Vario for Attachement of disposable collection system

Medela AG

Desk mount

• Primary Device ID: 07612367015387
• NIH Device Record Key: a2aa9ae2-e7e4-4217-962b-b66d23734f5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapter Vario
• Version Model Number: 077.0105
• Company DUNS: 488293218
• Company Name: Medela AG
• Device Count: 5
• 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	07612367015387 [Primary]
GS1	07612367052757 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153663

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

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

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• 07612367053150 - Invia Motion 60 Days NPWT: 2024-08-30 Negative Pressure Wound Therapy Powered Suction Pump - 087.4024
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• 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