OneMumPumpset D31 63.00.125

GUDID 00814079021657

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, single-use, sterile
Primary Device ID00814079021657
NIH Device Record Keyaccbf23a-40ba-49ed-b17e-cfaaba183247
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneMumPumpset D31
Version Model Number63.00.125
Catalog Number63.00.125
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 Datetrue
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

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079021640 [Primary]
GS100814079021657 [Package]
Contains: 00814079021640
Package: Box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-01

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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