Calypso-To-Go 63.00.243

GUDID 00814079020049

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.

Ardo medical AG

Breast pump support kit, reusable

• Primary Device ID: 00814079020049
• NIH Device Record Key: a9130339-d15b-4d65-8fbe-4e99cb490e83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calypso-To-Go
• Version Model Number: 63.00.243
• Catalog Number: 63.00.243
• 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	00814079020032 [Primary]
GS1	00814079020049 [Package]; Contains: 00814079020032; Package: Box [38 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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: 2024-01-30 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