Calypso Essentials TX 63.00.320

GUDID 00814079021800

The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The package also contains an adapter for manual pumping as well as spare parts for the pumpset.

Ardo medical AG

Breast pump, electric

• Primary Device ID: 00814079021800
• NIH Device Record Key: b8c8f2c5-edf9-4d54-aadb-617bb061220b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calypso Essentials TX
• Version Model Number: 63.00.320
• Catalog Number: 63.00.320
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814079021800 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-23

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