Hands-Free Double Pumpset 63.00.454

GUDID 07640108054494

The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression and collection of breast milk. The pumpset can be used as a single or double pumpset.

Ardo medical AG

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• Primary Device ID: 07640108054494
• NIH Device Record Key: fd4b450b-7fd0-4b5e-bd29-e4eb00deb5cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hands-Free Double Pumpset
• Version Model Number: 63.00.454
• Catalog Number: 63.00.454
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640108054494 [Primary]

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: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by Ardo medical AG

• 07640108054470 - Alyssa Hands-Free: 2024-01-30 Breast Pump, electric, with hands-free-pumpset
• 07640108054494 - Hands-Free Double Pumpset: 2024-01-30The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression and collection of breast milk. The pumpset can be used as a single or double pumpset.
• 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