FDA.reportPublic FDA data

Calypso To Go Pure

Primary DI
00814079021909
Brand
Calypso To Go Pure
Company
Ardo medical AG
Model
63.00.330
Catalog number
63.00.330
Device description
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.
Published
2018-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141742000ARDO CARUM AND CALYPSO POWERED BREAST PUMPSArdo Medical AG2014-10-17HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814079021909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814079021909008140790219098140790219090814079021909

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18444112736customer-service@ardo-usa.com
+41417547070info@ardo.ch

Regulatory Flags#

DUNS number
481670396
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640108054975Ardo Melia63.00.57163.00.5712026-02-27
07640108054982Ardo Melia63.00.57163.00.5712026-02-27
07640108051080Alyssa Hands-Free to-go63.00.51363.00.5132025-09-15
07640108055507Hospital Kit DeTach 21 mm63.00.47663.00.4762025-08-27
07640108055521Hospital Kit DeTach 24 mm63.00.47763.00.4772025-08-27
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter30.00.22 / UP033C30.00.222025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V31.00.22 / UP030C31.00.222025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V30.00.24 / UP034C30.00.242025-07-16
07640108054470Alyssa Hands-Free63.00.45363.00.4532024-01-22
07640108054494Hands-Free Double Pumpset63.00.45463.00.4542024-01-22
00814079020094Amaryll63.00.19063.00.1902022-08-04
00814079020872Double Clinic Pumpset63.00.28363.00.2832016-09-22
00814079022203Double Clinic Pumpset63.00.55563.00.5552023-09-06
00814079022210Double Clinic Pumpset63.00.55563.00.5552023-09-06
07640108051516Bellis63.00.52463.00.5242023-05-24
07640108053961Alyssa to-go63.00.51163.00.5112023-05-24
00814079021862Tulips Size S63.00.2363.00.232023-05-23
00814079022104Tulips Size S63.00.32363.00.3232023-05-23
07640109059627Tulips Size S63.00.2363.00.232023-05-23
00814079022111Tulips Size S63.00.32363.00.3232023-05-23

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