Double Clinic Pumpset 63.00.283

GUDID 00814079020872

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 ID00814079020872
NIH Device Record Key6bd58756-c08b-454c-b7e6-54cb735c1c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Clinic Pumpset
Version Model Number63.00.283
Catalog Number63.00.283
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
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079020872 [Primary]
GS100814079020889 [Package]
Package: Box [18 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-22

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.