Double Clinic Pumpset 63.00.555

GUDID 00814079022210

The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to 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.

Ardo medical AG

Breast pump support kit, reusable
Primary Device ID00814079022210
NIH Device Record Keyc2ddb9e5-fdce-40c2-a332-e6c2f8cb93d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Clinic Pumpset
Version Model Number63.00.555
Catalog Number63.00.555
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 Batchtrue
Serial Numberfalse
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
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079022203 [Primary]
GS100814079022210 [Package]
Contains: 00814079022203
Package: Box [45 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

On-Brand Devices [Double Clinic Pumpset]

00814079020872The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used
00814079022210The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used

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