FDA.reportPublic FDA data

Double Pumpset

Primary DI
00814079020933
Brand
Double Pumpset
Company
Ardo medical AG
Model
63.00.222
Catalog number
63.00.222
Device description
The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating womento express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.
Published
2016-09-22
Public version status
Update
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
00814079020940PackageGS18In Commercial Distribution
00814079020933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814079020940008140790209408140790209400814079020940
00814079020933008140790209338140790209330814079020933

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18444112736customer-service@ardo-usa.com
+414174547070info@ardo.ch

Regulatory Flags#

DUNS number
481670396
Device count
1
Lot or batch
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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