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 ID00814079021800
NIH Device Record Keyb8c8f2c5-edf9-4d54-aadb-617bb061220b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalypso Essentials TX
Version Model Number63.00.320
Catalog Number63.00.320
Company DUNS481670396
Company NameArdo medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079021800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-23

Devices Manufactured by Ardo medical AG

07640108054470 - Alyssa Hands-Free2024-01-30 Breast Pump, electric, with hands-free-pumpset
07640108054494 - Hands-Free Double Pumpset2024-01-30 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 Pumpset2023-09-14 The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
07640108051516 - Bellis2023-06-01 Breast Pumps, electric, with cooling bag
07640108053961 - Alyssa to-go2023-06-01 Breast Pump, electric, with carry bag
07640109059627 - Tulips Size S2023-05-31 Nipple Shields Size S
00814079022111 - Tulips Size S2023-05-31 Nipple Shields Size S
07640108053640 - Alyssa Double Plus2022-08-25 Breast Pump Double, electric

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