OneMumPumpset D31 63.00.125

GUDID 00814079021657

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

Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile

• Primary Device ID: 00814079021657
• NIH Device Record Key: accbf23a-40ba-49ed-b17e-cfaaba183247
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneMumPumpset D31
• Version Model Number: 63.00.125
• Catalog Number: 63.00.125
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814079021640 [Primary]
GS1	00814079021657 [Package]; Contains: 00814079021640; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172067

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-01

Devices Manufactured by Ardo medical AG

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• 07640108054494 - Hands-Free Double Pumpset: 2024-01-30 The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression an
• 00814079022210 - Double Clinic Pumpset: 2023-09-14 The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
• 07640108051516 - Bellis: 2023-06-01 Breast Pumps, electric, with cooling bag
• 07640108053961 - Alyssa to-go: 2023-06-01 Breast Pump, electric, with carry bag
• 07640109059627 - Tulips Size S: 2023-05-31 Nipple Shields Size S
• 00814079022111 - Tulips Size S: 2023-05-31 Nipple Shields Size S
• 07640108053640 - Alyssa Double Plus: 2022-08-25 Breast Pump Double, electric