Accessories for Vario 18 pump

GUDID 07612367022903

Accessories for Vario 18 pump consisting of overflow protection / bacteria filter 077.0571

Medela AG

Suction system filter, microbial

• Primary Device ID: 07612367022903
• NIH Device Record Key: b77f8520-7530-4636-9ebe-96fba34c0487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessories for Vario 18 pump
• Version Model Number: 080.0009
• 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	07612367022903 [Primary]

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: 2016-10-14

On-Brand Devices [Accessories for Vario 18 pump]

• 07612367022910: Accessories for Vario 18 pump consisting of disposable tubing (077.0952)
• 07612367022903: Accessories for Vario 18 pump consisting of overflow protection / bacteria filter 077.0571