Double Clinic Pumpset 63.00.555

GUDID 00814079022210

The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.

Ardo medical AG

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• Primary Device ID: 00814079022210
• NIH Device Record Key: c2ddb9e5-fdce-40c2-a332-e6c2f8cb93d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Double Clinic Pumpset
• Version Model Number: 63.00.555
• Catalog Number: 63.00.555
• Company DUNS: 481670396
• Company Name: Ardo medical 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814079022203 [Primary]
GS1	00814079022210 [Package]; Contains: 00814079022203; Package: Box [45 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141742

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [Double Clinic Pumpset]

• 00814079020872: The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used
• 00814079022210: The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used